BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT

    MDR report key: 1233343 · Received November 5, 2008

    Report

    Report Number
    1233343
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 5, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE TAUT CHOLANGIOCATHETER WAS FOUND TO HAVE A HOLE WHERE THE TUBING AND METAL MEET AT THE DISTAL END OF THE DEVICE. THE DEVICE HAD BEEN INSERTED WHEN THE LEAK WAS FOUND. THE PHYSICIAN ELECTED TO NOT USE IT FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT CATHETER, CHOLANGIOGRAM GBZ TELEFLEX MEDICAL 20018-M55 01F0800030

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR