BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW QUICKFLASH RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 3821835 · Received May 9, 2014

    Report

    Report Number
    3821835
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH THIS ISSUE. INSERTED ARTERIAL LINE INTO RADIAL ARTERY. GOT BLOOD FLASH BACK. INSERTED GUIDEWIRE AND ADVANCED SHEATH. FELT RESISTANCE. RETRACTED. AFTER RETRACTED A LUMP WAS NOTED UNDER THE SKIN. CATHETER HAD HALF OF SHEATH MISSING. HALF OF SHEATH REMAINED UNDER THE SKIN. SURGEON WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282384 ARROW QUICKFLASH RADIAL ARTERY CATHETERIZATION SET A-LINE DQY ARROW INTERNATIONAL, INC. CF1022794

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention