BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 11595040 · Received March 31, 2021

    Report

    Report Number
    1911916-2021-00265
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 29, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0143354, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2020-05-22. MEDICAL DEVICE LOT #: 0143355, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2020-05-22. MEDICAL DEVICE LOT #: 0051438, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-02-20. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBERS 0143354. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO AID IN THE INVESTIGATION, SIXTEEN SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE SELECTED BY THE CUSTOMER WHILE INSPECTING PARTS UNDER A MICROSCOPE. BASED ON OUR EVALUATION, ONLY TWO OF THE SAMPLES COULD BE CONSIDERED MARGINALLY DEFECTIVE. THE REST OF THE SAMPLES ARE IMPERFECTIONS. THE SAMPLES WERE SENT TO THE VENDOR FOR FURTHER ANALYSIS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT NUMBER 0143355. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO AID IN THE INVESTIGATION, FIFTEEN SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE SELECTED BY THE CUSTOMER WHILE INSPECTING PARTS UNDER A MICROSCOPE. BASED ON OUR EVALUATION, ONLY FIVE OF THE SAMPLES COULD BE CONSIDERED DEFECTIVE. THE REST OF THE SAMPLES HAVE IMPERFECTIONS. THE SAMPLES WERE SENT TO THE VENDOR FOR FURTHER ANALYSIS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT NUMBER 0051438. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO AID IN THE INVESTIGATION, THIRTEEN SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE SELECTED BY THE CUSTOMER WHILE INSPECTING PARTS UNDER A MICROSCOPE. BASED ON OUR EVALUATION, ONLY ONE OF THE SAMPLES COULD BE CONSIDERED DEFECTIVE. THE REST OF THE SAMPLES HAVE IMPERFECTIONS. THE SAMPLES WERE SENT TO THE VENDOR FOR FURTHER ANALYSIS. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD¿ BLUNT FILL NEEDLE WITH FILTER EACH FROM LOTS 0143354, 0143355, AND 0051438 WERE FOUND WITH DAMAGED/CRACKED NEEDLE HUBS DURING A "PRE-INSPECTION". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT SEEMS THAT THE TWO EXISTING COMPLAINTS ARE BOTH RELATED TO THE FUNCTIONAL FAILURES AND THE PICTURES OF THE ¿PRE-INSPECTION¿ HAD NOT BEEN PREVIOUSLY CAPTURED AS A COMPLAINT. THEREFORE, I THINK WE DO NEED TO OPEN A 3RD COMPLAINT ON THIS SPECIFICALLY RELATED TO THE ¿PRE-INSPECTION¿ THAT THEY DID USING MICROSCOPY. PLEASE CODE THIS AS DAMAGE NOT LEAKAGE, SINCE THESE PARTS WERE NOT FUNCTIONALLY TESTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496570 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 SEE SECTION H.10. 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1