Medical Devices
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
Products:
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
