• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Recalls of Q-Syte™ Luer Access Split Septum and Products Containing the Q-Syte™ Luer Access Split Septum: Initial Communication

Date Issued: March 17, 2010

Audience: Hospitals, clinics, patients with central venous and peripheral catheters

Medical Specialty: General hospital

Photo 1. BD Q-Style Luer Access Split SeptumProducts:

Certain lots of the Becton Dickinson and Company (BD) Q-Syte™ Luer Access Split Septum device and other finished products, including kits and trays, sold by other companies in which the Q-Syte™ Luer access device is a component are being recalled. This includes:

  • Certain BD Q-Syte Luer Access Split Septum devices
  • Certain BD Nexiva Closed Catheter Systems
  • Certain MPS Acacia IV extension sets
  • Certain Medical Action Industries IV start bundle kits, venous access trays, and dialysis kits
  • Certain Arrow International central venous access kits and sheath introducer kits

See the “Recalled Devices” attachment at the end of this document for specific information on the affected products.

Summary of Problem and Scope:

FDA has become aware that certain lots of the BD Q-Syte™ Luer access device are defective and may be hazardous to patients and staff. In the affected units, the bottom disk of the septum was cut during manufacturing. Note that the defect cannot be detected visually prior to use.

A defective septum may allow air to leak into the patient’s bloodstream, resulting in an air embolism. Other reported adverse consequences include leakage of infused therapy fluids, which could result in incomplete and inadequate administration, and leakage of blood. These events could result in:

  • hypotension,
  • hemodynamic instability,
  • a need for blood transfusions,
  • blood-borne infections, and
  • other serious injuries or death to the patient.

Leakage could also expose healthcare practitioners to blood-borne infectious agents and to hazardous drugs such as chemotherapeutic agents.

According to BD, between November 2008 and October 2009, the company received 30 reports of adverse events including an infant in France who suffered from an air embolus associated with the Q-Syte™ Luer access.

FDA is continuing to investigate the problem and to work with BD to identify other companies and manufacturers that have distributed the recalled Q-Syte™ Luer access devices as a component of other kits and trays. FDA will provide additional information as it becomes available.

Recommendations/Actions:

Health care professionals

  • Check the lot numbers on the product packaging to determine if your devices are affected by the recalls. (Refer to the list of recalled products at the end of this document.)
  • Do not use affected Q-Syte™ Luer access products.
  • If you cannot determine whether your device is affected by these recalls, do not use it.
  • If a patient has already been fitted with a Q-Syte™ Luer access device and you cannot determine its lot number, replace the Q-Syte™ Luer access device with one that is not affected by the recall as soon as possible.
  • Return all affected products to the recalling company.

Medical facilities, consignees and distributors

  • Inspect your inventory for products that may contain the recalled devices and return all affected products to the recalling company.

Patients receiving treatment at home

  • If you think your catheter may be fitted with a Q-Syte™ Luer access device, contact your home health provider or medical supplies provider.

Reporting Problems to FDA:

Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a Q-Syte™ Luer access device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.

Additional Information:

Other documents associated with this issue can be found at:

This document reflects FDA’s current analysis of available information, in keeping with our commitment to promptly inform healthcare professionals and the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.


ATTACHMENT: RECALLED DEVICES

Becton Dickinson Medical Systems

Product 1. BD Q-Syte, Luer access connector

Catalog # REF 385100

Description: BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

8268863 8269020 8275798 8308321
8308323 8309553 8331937 8331940
8354558 9007921 9009643 9009646
9028838 9035029 99035032  
Product 2. BD Q-Syte Extension Set, Luer access extension

Catalog # REF 385101

Description: BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8305510
  • 8331944
Product 3. BD Q-Syte Extension Set, Luer access extension

Catalog # REF 385102

Description: BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8305511
  • 8308330
  • 8354561
  • 9012072
Product 4. BD Q-Syte Vial Access Adapter, Luer access adapter

Catalog # REF 385108

Description: BD Q-Syte Vial Access Adapter, 0.16 ml, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 9007918
  • 9035042
  • 9035044
Product 5. MPS Acacia Extension Set, Luer access extension

Catalog # REF 385150

Description: MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/ BBD Q- Syte

Lots Affected:

  • A1967
  • A1979
  • A2056
Product 6. MPS Acacia Extension Set, Luer access extension

Catalog # REF 385151

Description: MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte

Lots Affected:

A1950

A2399

Product 7. MPS Acacia Tri-Extension Set, Luer access extension

Catalog # REF 385164

Description: MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte

Lots Affected:

  • A1951
Product 8. Closed IV Catheter system

Catalog # REF 383530

Description: BD Nexiva Closed IV Catheter System, 24GA 0.56IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8238450
  • 8319936
  • 8345957
  • 9013868
Product 9. Closed IV Catheter system

Catalog # REF 383531

Description: BD Nexiva Closed IV Catheter System, 24GA 0.75IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

8284049 8284050
8305438 8308349
8345951 9013867
9026722  
Product 10. Closed IV Catheter system

Catalog # REF 383532

Description: BD Nexiva Closed IV Catheter System, 22GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

8248349 8259950 8295761 8296792
8296793 8309299 8309662 8311150
8319961 8322609 8331771 8338737
8338738 8358628 9020033  
Product 11. Closed IV Catheter system

Catalog # REF 383533

Description: BD Nexiva Closed IV Catheter System, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8291980
  • 8330279
Product 12. Closed IV Catheter system

Catalog # REF 383534

Description: BD Nexiva Closed IV Catheter System, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8331763
Product 13. Closed IV Catheter system

Catalog # REF 383536

Description: BD Nexiva Closed IV Catheter System, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

8248355 8249034 8249035 8269338 8270576
8274565 8275207 8275210 8283964 8311167
8312211 8319016 8347056 9007360 9015539
9022039        
Product 14. Closed IV Catheter system

Catalog # REF 383537

Description: BD Nexiva HF Closed IV Catheter System, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8263294
  • 8270579
  • 8347058
  • 9013864
Product 15. Closed IV Catheter system

Catalog # REF 383538

Description: BD Nexiva Closed IV Catheter System, 20GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8312220
Product 16. Closed IV Catheter system

Catalog # REF 383539

Description: BD Nexiva Closed IV Catheter System, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8263293
  • 8274555
  • 8275429
  • 8290311
  • 8340308
  • 9016819
Product 17. Closed IV Catheter system

Catalog # REF 383540

Description: BD Nexiva Closed IV Catheter System, 18GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 8340302
Product 18. Closed IV Catheter system

Catalog # REF 383647

Description: BD Nexiva Closed IV Catheter System, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 9034319
Product 19. Closed IV Catheter system

Catalog # REF 383649

Description: BD Nexiva Closed IV Catheter System, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc.

Lots Affected:

  • 9041552

Medical Product Specialist Inc / MPS Acacia

Product 1. IV Extension Set with BD Q-Syte

Catalog # 385150

Description: Extension Set 15cm Rightbore -18, Spin Nut w/BD Q-Syte

Lots Affected:

  • A1967
  • A1979
  • A2055
  • A2056
  • A2099
Product 2. IV Extension Set with BD Q-Syte

Catalog # 385151

Description: Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

Lots Affected:

  • A1950
Product 3. IV Extension Set with BD Q-Syte

Catalog # 385164

Description: Tri-Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte

Lots Affected:

  • A1951
Product 4. IV Extension Set with BD Q-Syte

Catalog # 385165

Description: "Y" Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte

Lots Affected:

  • A2100
  • A2101
Product 5. IV Extension Set with BD Q-Syte

Catalog # 385166

Description: Dual "Y" Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte

Lots Affected:

  • A2104

Medical Action Industries Inc.

Product 1. Medical Action Industries, IV Start bundle kit

Catalog/Part # 69946B

Description: Bundle Kit, using MPS Acacia with BD QSyte" (BD #385151)

Lots Affected:

  • 62295
  • 63591
  • 64197
  • 65175
  • 67162
  • 69906
  • 72113
  • 73617
Product 2. Medical Action Industries, venous access tray

Catalog/Part # 69498

Description: Medical Action Industries, Venous Access Tray, using BD Q-Syte" Luer Access Split Septum (BD #385100)

Lots Affected:

  • 62282
  • 69902
  • 70350
  • 70854
  • 72108
Product 3. Medical Action Industries, Dialysis kit

Catalog/Part # 57977

Description: Medical Action Industries, Dialysis Kit, using BD Q-Syte" Luer Access Split Septum (BD #385100)

Lots Affected:

  • 62394
  • 63042
  • 64820

Arrow International Inc.

Product 1. MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device

Catalog/Part # ASK-21242-UVA2

Description: MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Lots Affected:

  • RF9068459
  • RF9060775
Product 2. Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath

Catalog/Part # ASK-29803-SJH

Description: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Lots Affected:

  • RF9044900
  • RF9068155
Product 3. Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter

Catalog/Part # ASK-42703-SJH

Description: Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Lots Affected:

  • RF9055789
  • RF9071896
Product 4. Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter

Catalog/Part # ASK-42802-SHB

Description: Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte)

Lots Affected:

  • RF9068926
Product 5. Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter

Catalog/Part # ASK-45703-SHB

Description: Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)

Lots Affected:

  • RF9071258
  • RF9069621
Product 6. Multi-Lumen Central Venous Catheterization Kit with Blue Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter

Catalog/Part # ASK-45703-UVA2

Description: Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte)

Lots Affected:

  • RF9056115
  • RF9056743
  • RF9060775