BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 3181476 · Received May 11, 2013

    Report

    Report Number
    3181476
    Event Type
    Malfunction
    Date Received
    May 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    May 7, 2013
    Manufacturer
    TELEFLEX
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN LEFT THE PT'S ROOM AFTER SETTLING HER IN FROM PACU. EVERYTHING WAS INTACT AT THAT TIME. A SHORT TIME LATER RN WAS CALLED TO THE ROOM BECAUSE THE FOLEY CATHETER HAD SNAPPED OFF JUST ABOVE WHERE THE THICK PART OF THE FOLEY ATTACHES TO THE URINE COLLECTION SYSTEM.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
    209829 RUSCH CATHETER, UROLOGICAL KOD TELEFLEX UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR