BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREINER BIO-ONE VACUETTE QUICKSHIELD COMPLETE PLUS

    MDR report key: 5017460 · Received August 20, 2015

    Report

    Report Number
    5017460
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 13, 2015
    Report Date
    August 12, 2015
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN DRAWING PATIENT, (MINT) TUBE POPPED OUT OF NEEDLE HOLDER, PATIENT JUMPED SO I THEN TOOK NEEDLE OUT OF PATIENT ARM. PATIENT WAS OK BUT STATED THAT IT WAS SCARY. I STILL WAS ABLE TO GET BLOOD. WE ALSO HAD THREE OTHER EVENTS INVOLVING THE SAME TYPE OF NEEDLE ON THE SAME DAY. HOWEVER, WE WERE NOT ABLE TO CAPTURE THE LOT NUMBER ON THOSE PARTICULAR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550846 GREINER BIO-ONE VACUETTE QUICKSHIELD COMPLETE PLUS NEEDLE,HYPODERMIC, SINGLE FMI GREINER BIO-ONE NORTH AMERICA INC. G150233C

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR