BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH PEDIATRIC FOLEY CATHETER

    MDR report key: 3164069 · Received June 7, 2013

    Report

    Report Number
    3164069
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    TELEFLEX, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    NURSE PLACED A 6FR CATHETER FOR VOIDING CYSTOURETHROGRAM (VCUG) PROCEDURE. WHEN SHE ATTEMPTED TO WITHDRAW THE GUIDE WIRE, THE WIRE CAUSED THE CATHETER TO PUCKER, AND SHE COULD NOT WITHDRAW THE GUIDE WIRE. THEN NOTED A HOLE IN CATHETER NEAR THE TOP WHERE THE CATHETER LINE MEETS THE ADAPTER AREA. THE GUIDE WIRE WAS EASILY SEEN THROUGH THE HOLE IN THE CATHETER. NO HOLE WAS NOTED BEFORE PLACING. TESTED THE GUIDE WIRE; EASE OF WITHDRAW ABOUT 1 CM BEFORE PLACING CATHETER. NO STICKING NOTED BEFORE PLACING. IT APPEARS THE GUIDE WIRE CAUGHT ON SOMETHING AT THE VERY END OF THE CATHETER JUST IN THE PLACE WHERE THE GUIDE WIRE EXITS THE CATHETER. UPON FURTHER INSPECTION BY CLINICAL ENGINEERING OF THE CATHETER A HOLE COULD NOT BE FOUND AS REPORTED. HOWEVER THE REASON THIS REPORT IS BEING FILED IS BECAUSE THE NURSE HAD TO INSERT ANOTHER CATHETER WHICH CAUSED THIS PEDIATRIC PATIENT SOME DISCOMFORT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NOT KNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253416 RUSCH PEDIATRIC FOLEY CATHETER CATHETER, UROLOGICAL, PEDIATRIC KOD TELEFLEX, INC. * 12LE49

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO