BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLASH

    MDR report key: 4100695 · Received July 16, 2014

    Report

    Report Number
    4100695
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ANESTHESIOLOGIST WAS INSERTING THE ARTERIAL LINE AND THE CATHETER COVERED NEEDLE WAS INSERTED INTO THE ARTERY. THE WIRE WAS ADVANCED, THEN THE CATHETER, WITH PRESSURE WAS HELD ON THE ARTERY. WHEN THE ANESTHESIOLOGIST WITHDREW THE NEEDLE FROM THE CATHETER, THE PLASTIC HUB OF THE NEEDLE DISENGAGED FROM THE NEEDLE, LEAVING THE NEEDLE IN THE CATHETER AND ONLY THE HUB IN HIS HAND. THEY WERE BARELY ABLE TO SEE THAT THE NEEDLE WAS STILL IN THE ARTERY, AND THE NEEDLE WAS RETREIVED WITH A MAYO CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416017 QUICKFLASH CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL, INC. * 14A0471

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR