BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE SAFETY BLOOD COLLECTION SET

    MDR report key: 4053895 · Received August 11, 2014

    Report

    Report Number
    4053895
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 8, 2014
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    AS THE PHLEBOTOMIST WAS COMPLETING THE BLOOD SPECIMEN DRAW AND PULLING THE NEEDLE OUT, THE NEEDLE DID NOT CONTRACT ALL THE WAY INSIDE THE PLASTIC SAFETY TUBE CAUSING A PORTION OF THE NEEDLE TO BE EXPOSED WHICH RESULTED IN A NEEDLE STICK TO THE STAFF MEMBER. THERE WAS NO PATIENT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477080 VACUETTE SAFETY BLOOD COLLECTION SET NEEDLE, HYPODERMIC, SINGLE LUMEN FMI GREINER BIO-ONE NORTH AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES