BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® TRACE ELEMENT SERUM PLUS TUBE, 6.0ML, 13X100MM

    MDR report key: 7058838 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00354
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 14, 2016
    Report Date
    November 6, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903683802
    PMA / PMN Number
    K041071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: 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 CRACKED TUBE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5210518 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® TRACE ELEMENT SERUM PLUS TUBE, 6.0ML, 13X100MM TUBE WAS CRACKED UPON REMOVAL FROM THE CENTRIFUGE. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838797 BD VACUTAINER® TRACE ELEMENT SERUM PLUS TUBE, 6.0ML, 13X100MM BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5210518 00382903683802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other