Inspections, Compliance, Enforcement, and Criminal Investigations
Pyng Medical Corporation 5/12/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Center for Devices and
9200 Corporate Blvd
Rockville, MD 20850
MAY 12 2009
President & CEO
Pyng Medical Corp.
13511 Crestwood PI Rm. 7
Richmond, B.C. V6V 2E9 Canada
Dear Mr. Christie:
During an inspection of your firm located in Richmond, Canada, on December 8, 2008, through December 11, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Fast Access for Shock and Trauma, FAST1. Under section 401 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
Our inspection revealed that your FAST1 device is misbranded under section 502(t)(2) of the Act 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR. Part 803 - Medical Device Reporting (MDR) regulation Significant deviations include, but are not limited to, the following:
1) Failure to report to the FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
Specifically, no MDR reports were filed for the following FASTI complaints:
1) Complaint #142, which was received by your firm on January 11, 2007, was a report of three instances in which the device failed insertion during attempted use on patients.
2) Complaint #146, which was received by your firm on April 23, 2007, was a report of an incident in which the portal tip of the insertion tubing of the device disconnected during attempted removal of the insertion tubing from the chest of the patient. The complaint file noted that removal of the portal tip would have required surgical intervention.
3) Complaint #151, which was received by your firm on August 8, 2007, was a report of an incident in which the device failed insertion during attempted use on a patient.
We have reviewed your responses and have concluded that they are inadequate for the following reasons:
Your first response, incorrectly dated January 9, 2008, does not adequately address the MDR issues identified during the establishment inspection. Furthermore, despite your claim of having submitted a report, as of March 27, 2009, the FDA has not received a MDR from Pyng Medical for Complaint #142.
Your second response, incorrectly dated January 16,2008, (which should have been January 16,2009) provides your explanation for non-reporting. Your response demonstrates a lack of understanding of the Medical Device Reporting requirements of 21 CFR Part 803, and a misunderstanding of the definitions of "caused or contributed to" a"MDR reportable event." Furthermore, despite your claim of having submitted five MDRs; 9615387-2009-00002, 9615387-2009-00003, 9615387-2009-00004, 96153872009-00005 and 9615387-2009-00006, the FDA has no record of receiving these reports.
Your third response, dated January 30,2009, asserts that nine complaints were reviewed by Pyng Medical and determined not to reflect reportable malfunction events. The explanations given included:
• " the devices were returned ...no device malfunction ..."
• " no evidence of malfunction for devices of similar [sic] lot. .."
• " .. .investigation clearly identified a root cause for the complaint that was not related to a malfunction of the product..."
The complaint files listed above contain information that reasonably suggests that your device did not perform as intended, i.e. it failed to provide intraosseous access for emergency fluid infusions or disconnected during attempted removal resulting in a situation where medical intervention may have been necessary. Your firm determined that the reported failures did not represent malfunction events, however, you failed to provide any documentation in your files that would support this decision. Therefore, the events meet the definition of reportable malfunctions.
2) Failure to conduct an investigation of each event and evaluate the cause of the event as required by 21 CFR Part 803.50(b)(3).
Your complaint files do not contain information to suggest that your firm conducted a complete investigation about each of the reported events, including whether consequences to the patient as a result of the device failure may have represented events that should have been submitted to FDA as reportable death or serious MDRs. Your firm needs to make a reasonable effort to find out and document, what happened to the patient as a result of the reported failure, in addition to determining why the device failed to perform as intended.
3) Failure to develop, maintain, and implement written MDR procedures for the following:
a) Internal systems that provide for:
1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
b) Documentation and recordkeeping requirements for:
1) Information that was evaluated to determine if an event was reportable;
2) All medical device reports and information submitted to manufacturers and/or us;
3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
4) Systems that ensure access to information that facilitates timely follow-up and inspection by us.
Specifically, your Medical Device Reporting procedure (b)(4) is inadequate and would not provide for timely and effective identification, communication and evaluation of events subject to the MDR requirements. Therefore, your MDR procedure does not comply with the requirements of 21 CFR Part 803.17.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed; Section 801(a) of the Act (21 U.S.C. § 381(a)). Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations,including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to
facilitate our review.
Your response should be sent to: Valerie A. Flournoy, Branch Chief, General Hospital Devices Branch, HFZ-333, 9200 Corporate Blvd, Rockville, MD 20850. If you have any questions about the content of this letter please contact: Valerie A. Flournoy at 240-276-0115 or FAX 204-276-0114.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and