BEUDAMED
    FDA Adverse Event Other Summary report: N

    23X12" SAFETY BLOOD COLLECTION SET LA

    MDR report key: 3199576 · Received June 25, 2013

    Report

    Report Number
    8020040-2013-00002
    Event Type
    Other
    Date Received
    June 25, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K011786
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE NOT RETURNED. NO DEFECT COULD BE FOUND ON RETAIN SAMPLES NOT UNUSED CUSTOMER RETURNED SAMPLES.

    Description of Event or Problem · 1

    CUSTOMER ADVISES A NEEDLE STICK INJURY OCCURRED WHILE USING ITEM 450096. CUSTOMER STATES THAT AFTER TERMINATING THE VENIPUNCTURE AND FULLY ACTIVATING THE DEVICE SAFETY, THE PHLEBOTOMIST LIFTED THE SBC AWAY FROM THE PT'S ARM TO DISCARD THE DEVICE. WHEN MOVING THE DEVICE, THE NEEDLE FELL-OUT FROM THE FRONT-END AND LANDED ON THE PT'S BED. PICKING UP THE NEEDLE WITH HIS/HER FINGERS THE PT MOVED AND THE NEEDLE STUCK THE PHLEBOTOMIST IN THE HAND. CUSTOMER STATES THIS WAS A NORMAL VENIPUNCTURE BUT THE PT WAS RESTLESS. CUSTOMER STATES THAT THE SAFETY DID "CLICK" WHEN ACTIVATED. CUSTOMER DISCARDED THE SAMPLE SO NO PHOTOS CAN BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289353 23X12" SAFETY BLOOD COLLECTION SET LA SBC SET FMI GREINER BIO-ONE GMBH 13A13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other