BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7498815 · Received May 9, 2018

    Report

    Report Number
    1917413-2018-02572
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    June 6, 2017
    Report Date
    April 27, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 7033705, MEDICAL DEVICE EXPIRATION DATE: 02/28/2018, DEVICE MANUFACTURE DATE: 02/02/2017. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD HAD ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342801 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7100534 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Other