BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® NO ADDITIVE (Z) TUBES

    MDR report key: 7578754 · Received June 7, 2018

    Report

    Report Number
    1917413-2018-02216
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    July 21, 2016
    Report Date
    May 14, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDW
    UDI-DI
    50382903667036
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® NO ADDITIVE (Z) TUBES POWER PROCESSOR WAS HAVING TROUBLE DECAPPING THEIR NON ADDITIVE TUBE (366703). AS A RESULT, THE PROBES WERE CRASHING INTO THE TOP AND CAUSING ANALYZER DOWNTIME. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423018 BD VACUTAINER® NO ADDITIVE (Z) TUBES SPECIMEN TRANSPORT AND STORAGE CONTAINER KDW BECTON, DICKINSON & CO. UNKNOWN 50382903667036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other