BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PLUS PLASTIC PLASMA TUBE

    MDR report key: 3961171 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00111
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN RECEIVED AND ARE CURRENTLY BEING EVALUATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THERE WAS AN OILY SUBSTANCE FROM THE GEL TUBES, CAUSING ERRONEOUS RESULTS WITH THE CEA, AFP AND ESTRADIOL TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314927 BD VACUTAINER PLUS PLASTIC PLASMA TUBE VENOUS BLOOD COLLECTION TUBE JKA BECTON DICKINSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK