BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SILCOMED

    MDR report key: 3021408 · Received February 15, 2013

    Report

    Report Number
    3021408
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 15, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO PLACE A 6 FRENCH FOLEY CATHETER, THE WIRE WITHIN THE FOLEY HAD TORN THROUGH THE SIDE OF THE CATHETER. THEREFORE THE WIRE EXPOSED WHILE TRYING TO PLACE THE FOLEY INTO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69943 RUSCH SILCOMED CATHETER, FOLEY KOD TELEFLEX MEDICAL 17000306 *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO