BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE

    MDR report key: 8088601 · Received November 20, 2018

    Report

    Report Number
    8088601
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 2, 2018
    Report Date
    November 16, 2018
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    FMI
    UDI-DI
    19120017570247
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLOOD COLLECTION SET TWISTS BACK ONTO ITSELF CAUSING THE PHLEBOTOMIST TO HAVE TO HOLD THE COLLECTION SET WHILE ATTEMPTING TO WITHDRAW NEEDLE. NEEDLE DOES NOT RETRACT COMPLETELY AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932892 VACUETTE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI GREINER BIO-ONE NORTH AMERICA, INC. 450082 17L03U 19120017570247

    Patients

    Seq Age Sex Outcome Treatment
    1