BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 864383 · Received June 8, 2007

    Report

    Report Number
    MW5002605
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    June 6, 2007
    Report Date
    June 8, 2007
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD PLACED TRIPLE LUMEN VENOUS CATHETER IN FEMORAL. WHEN MD PULLED OUT THE GUIDEWIRE, ONLY HALF OF THE WIRE CAME OUT. PT. WENT TO INTERVENTIONAL RADIOLOGY TO CONFIRM BROKEN WIRE AND HAVE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. TRIPLE LUMEN CATHETER DQO UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR