BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE

    MDR report key: 7411159 · Received April 10, 2018

    Report

    Report Number
    7411159
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 30, 2018
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHITE DEBRIS IN CHUNKS OF THE 8 ML Z SERUM SEP CLOT ACTIVATOR THAT WOULD NOT DISSOLVE IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259067 VACUETTE TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA GREINER BIO-ONE GMBH 455071P B170103KT

    Patients

    Seq Age Sex Outcome Treatment
    1