BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2850037 · Received November 27, 2012

    Report

    Report Number
    2850037
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARROW
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AFTER PLACEMENT OF THE RADIAL ARTERIAL CATHETER, THE PHYSICIAN HAD A DIFFICULT TIME TRYING TO REMOVE THE GUIDE WIRE. THEY ENDED UP HAVING TO GUIDE THE NEEDLE BACK IN AND REMOVE THE WHOLE THING. AFTER REMOVAL OF THE GUIDE WIRE FROM THE PATIENT, IT WAS NOTICED THAT THE GUIDE WIRE WAS TWISTED AND BENT AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * WIRE, GUIDE, CATHETER DQX ARROW ASK-04510-HFH RF1128789

    Patients

    Seq Age Sex Outcome Treatment
    1 *