BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE CARE LUBRI-SIL I.C.

    MDR report key: 3073101 · Received April 18, 2013

    Report

    Report Number
    3073101
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    C.R. BARD, INC
    Product Code
    FCN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD URINARY CATHETER PLACED IN THE MORNING. APPROXIMATELY FOUR HOURS LATER, RN IDENTIFIED THAT THE FOLEY BAG WAS LEAKING URINE ONTO THE FLOOR. A SMALL SLIT OPENING WAS FOUND ON THE BACK OF THE CATHETER BAG. BAG AND TUBING NEEDED TO BE CHANGED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CATHETER INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167855 COMPLETE CARE LUBRI-SIL I.C. KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER FCN C.R. BARD, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR