BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFEPICO

    MDR report key: 2904570 · Received December 2, 2008

    Report

    Report Number
    1523456-2008-00005
    Event Type
    Other
    Date Received
    December 2, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CBT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DUE TO AN ALLEGED FAILURE IN THE FUNCTION OF A SAFETY DEVICE ON A SAFEPICO BLOOD SAMPLER A USER WAS STUCK BY A NEEDLE. THE CUSTOMER HAS CLAIMED THEY HEARD WHAT WAS THOUGHT TO BE THE CLICK INDICATING THAT THE SAFETY DEVICE WAS NOW ENGAGED COVERING THE NEEDLE. BUT THE SAFETY DEVICE SLID DOWN EXPOSING THE NEEDLE, RESULTING IN THE CUSTOMER BEING STUCK. IT HAS BEEN INFORMED THAT THE USER WHO WAS STUCK IS NOW TAKING ORAL MEDICATION. (TYPES OF MEDICINE HAS NOT BEEN COMMUNICATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFEPICO SAFEPICO CBT RADIOMETER MEDICAL APS SAFEPICO WE51

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other