BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROWGARD MULTI-LUMEN CVC SUPER KIT

    MDR report key: 525390 · Received April 30, 2004

    Report

    Report Number
    525390
    Event Type
    Other
    Date Received
    April 30, 2004
    Date of Event
    March 1, 2004
    Report Date
    April 1, 2004
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED SUBCLAVIAN TRIPLE LUMEN PROCEDURE. J-WIRE KEPT BENDING. PHYSICIAN UNABLE TO THREAD TRIPLE LUMEN OVER J-WIRE. AFTER MUCH MANIPULATION, WAS ABLE TO THREAD TRIPLE LUMEN. [THE J-WIRE WAS BENT IN THE MIDDLE WELL ABOVE THE J END OF THE WIRE. THE PHYSICIAN WAS EXPERIENCED WITH THE DEVICE AND HAD EXPERIENCED THE SAME INCIDENT EARLIER IN THE SAME DAY. BOTH INCIDENTS INVOLVED THE SAME DEVICE, MANUFACTURER AND LOT NUMBER.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD MULTI-LUMEN CVC SUPER KIT SUBCLAVIAN LINE CATHETER DQO ARROW INTERNATIONAL, INC. * 2005-10

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other