BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 16102052 · Received January 5, 2023

    Report

    Report Number
    1917413-2022-00822
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 6, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2109065, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, AND DEVICE MANUFACTURE DATE: 2022-04-19. MEDICAL DEVICE LOT #: 2080646, MEDICAL DEVICE EXPIRATION DATE: 2023-06-30, AND DEVICE MANUFACTURE DATE: 2022-03-21. INVESTIGATION SUMMARY: BD RECEIVED 100 SAMPLES FROM LOT 2080646, 80 SAMPLES FROM LOT 2109065, AND 4 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOS WERE EVALUATED SHOWING SHELF PACK TRAYS FROM EACH LOT AND TUBES WITH A NEEDLE DEVICE; THEY DO NOT SHOW THE CUSTOMER¿S FAILURE MODE. THE SAMPLES FROM BOTH LOTS WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. 10 SAMPLE TUBES FROM EACH LOT WERE FUNCTIONALLY TESTED AND THE ISSUE OF STOPPER FUNCTION WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS, NO ISSUES WITH THE STOPPER FUNCTION WERE OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM EACH LOT OF THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THERE WERE NO ISSUES RELATED TO STOPPER FUNCTION AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS, NO ISSUES WITH THE STOPPER FUNCTION WERE OBSERVED. BD WAS UNABLE TO CONFIRM AND/OR DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT OBSERVED IN THE SAMPLE, PHOTO, AND RETENTION TESTING. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K THERE WAS DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THIS EVENT OCCURRED/AFFECTED 200 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER WAS HARD AND IT WAS MORE DIFFICULT THAN USUAL TO INSERT THE NP NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645424 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown