BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES

    MDR report key: 9008560 · Received September 12, 2019

    Report

    Report Number
    1917413-2019-02061
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679619
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 1

    MATERIAL NO. 367961, BATCH NO. 9063877. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES LABELS ARE COMING OFF THE TUBES. THERE ARE 100 TUBES WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LABELS ON TUBES ARE COMING OFF AND STICKING TO OTHER TUBES IN PACKAGING AND THEY ARE NOT STAYING AFFIXED TO TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799577 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN(LH) 65 UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9063877 50382903679619

    Patients

    Seq Age Sex Outcome Treatment
    1 Other