BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7560137 · Received June 1, 2018

    Report

    Report Number
    1917413-2018-02262
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    October 13, 2017
    Report Date
    May 8, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RETURNED TO MANUFACTURER IS UNKNOWN. THE DATE OF INVESTIGATION WAS USED. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. BD RECEIVED SAMPLES & PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WAS OBSERVED. ADDITIONALLY, SAMPLES OF THE INCIDENT LOT WERE PREVIOUSLY SELECTED FROM RETAIN AND EVALUATED & TESTED AND UPON COMPLETION, NO ISSUES WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. THE CUSTOMER SAMPLES WERE NOT TESTED AS RETENTION SAMPLES HAD PREVIOUSLY BEEN TESTED. 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 THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBES HAD GEL ON TOP AFTER SPINNING AND CAUSED NO SERIOUS INJURY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405773 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7100516 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other