BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKFLASH RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 1870998 · Received September 30, 2010

    Report

    Report Number
    1870998
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    June 25, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DR. ATTEMPTED TO INSERT A RADIAL ARTERIAL LINE. AFTER INSERTING THE NEEDLE/CATHETER INTO THE ARTERY, HE WAS NOT ABLE TO REMOVE THE NEEDLE TO THREAD THE CATHETER INTO PLACE. IT WAS AS IF THE NEEDLE AND CATHETER WERE FUSED. HE REMOVED THE CATHETER/NEEDLE AND DECIDED TO ABORT THE ARTERIAL LINE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE NEEDLE WOULD NOT COME OUT OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKFLASH RADIAL ARTERY CATHETERIZATION SET WIRE, GUIDE,CATHETER, ANGIOGRAPHIC DQX ARROW INTERNATIONAL * CF0015463

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR