BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEPICO

    MDR report key: 4945370 · Received July 9, 2015

    Report

    Report Number
    4945370
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 29, 2015
    Report Date
    July 9, 2015
    Manufacturer
    RADIOMETER AMERICA, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ARTERIAL BLOOD GAS SAMPLE ATTEMPT TO RIGHT RADIAL ARTERY WAS INCOMPLETE. THE NEEDLE/SYRINGE WAS UNCAPPED WITH THE PLUNGER PULLED TO THE 1.0 CC MARK. UPON INSERTION INTO THE RADIAL ARTERY, WITH NEEDLE BEVEL UP AT 45 DEGREE ANGLE INTO FLOW DIRECTION, BLOOD RETURN WAS NOTED AS BRISK, AND FLOW IMMEDIATELY STOPPED JUST SHORT OF 0.5CC'S. THE RN WAS UNABLE TO DRAW ANY MORE BLOOD WITH THE DEVICE.A SECOND ATTEMPT TO LEFT RADIAL ARTERY USING SAME TECHNIQUE YIELDED THE SAME RESULTS. THE RN WAS AGAIN UNABLE TO DRAW MORE BLOOD WITH THE DEVICE. BOTH SAMPLES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447295 SAFEPICO ARTERIAL BLOOD SAMPLING KIT CBT RADIOMETER AMERICA, INC. 616-KIT 23G RT-50

    Patients

    Seq Age Sex Outcome Treatment
    1 *