BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE

    MDR report key: 3608190 · Received January 31, 2014

    Report

    Report Number
    3608190
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TUBING BROKE FROM THE WINGED AREA OF BLOOD COLLECTION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68412 VACUETTE CONTAINER, SPECIMEN, STERILE JKA GREINER BIO-ONE NORTH AMERICA, INC. * 13020

    Patients

    Seq Age Sex Outcome Treatment
    1 *