BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 3120103 · Received May 11, 2013

    Report

    Report Number
    3120103
    Event Type
    Malfunction
    Date Received
    May 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    May 7, 2013
    Manufacturer
    TELEFLEX, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE FOLEY LINE BROKE IN HALF WHERE THE CATHETER ATTACHES TO THE THICKER TUBING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CATHETERIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209651 RUSCH CATHETER, UROLOGICAL KOD TELEFLEX, INC. 6FR 1.5CC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO