BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 16051890 · Received December 27, 2022

    Report

    Report Number
    1917413-2022-00810
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 30, 2022
    Report Date
    December 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "NO SAMPLES AND 1 PHOTO WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTO WAS EVALUATED AND DOES NOT SHOW THE CUSTOMER¿S FAILURE MODE OF STOPPER FUNCTION. THEREFORE, 86 RETENTION SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. ADDITIONALLY, 10 RETENTION SAMPLES WERE FUNCTIONALLY TESTED AND THERE WERE NO ISSUES RELATED TO STOPPER FUNCTION OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE INVESTIGATION COMPLETED. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES CAP COMES OFF BUT THE RUBBER STOPPER STAYS INSIDE THE TUBE. THIS EVENT OCCURRED FOUR TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER REPORTS ONGOING ISSUE WITH STOPPER NOT FULLY REMOVED FROM BD VACUTAINER TUBES, IN THIS CASE IT IS FOR CAT 367960 LOT 2166083. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER PIR3047950, THIS IS THE 4TH TYPE OF TUBE PRESENTING THE ISSUE. OTHER CASES ARE 1862202, 1866778, 1838534. PER CUSTOMER, THE DECAPPER ON THEIR ROCHE 8100 PULLS THE HEMOGARD PORTION OF THE CAP OFF BUT THE RUBBER STOPPER STAYS BEHIND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444379 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 2166083 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown