BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE QUICKSHIELD

    MDR report key: 3960794 · Received July 23, 2014

    Report

    Report Number
    MW5037418
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 26, 2014
    Report Date
    July 22, 2014
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE WAS USING A VACUETTE QUICKSHIELD TO DRAW LAB WORK ON A PT. THE QUICKSHIELD COVER DID NOT WORK CORRECTLY CAUSING EMPLOYEE TO STICK HER FINGER AND HAVE AN EXPOSURE TO A PT. THIS WAS DISCOVERED TODAY UPON EMPLOYEE INCIDENT REPORT REVIEW. DIAGNOSIS OR REASON FOR USE: WAS USING VACUETTE QUICKSHIELD TO PERFORM PHELBOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429947 VACUETTE QUICKSHIELD NA JKA GREINER BIO-ONE NORTH AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other