BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROWGARDTRIPLE LUMEN CATHETER

    MDR report key: 627101 · Received July 26, 2005

    Report

    Report Number
    627101
    Event Type
    Other
    Date Received
    July 26, 2005
    Date of Event
    July 24, 2005
    Report Date
    July 26, 2005
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PLACING A TRIPLE LUMEN CATHETER. AS THE PHYSICIAN WAS REMOVING THE SPRING WIRE GUIDE IT UNWRAPPED ITSELF. THE PHYSICIAN WAS ABLE TO GET THE ENTIRE GUIDE WIRE OUT. THE GUIDE WIRE WAS NEVER TORN OR JAGGED, BUT IT WAS ABOUT SIX INCHES LONGER AND THE AREA WHERE IT UNWRAPPED WAS REAL THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARDTRIPLE LUMEN CATHETER TRIPLE LUMEN CATHETER DQO ARROW INTERNATIONAL, INC. * RF5060133 06085 0111

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR