BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO/HEALTHCARE

    MDR report key: 1712398 · Received May 18, 2010

    Report

    Report Number
    1712398
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    March 5, 2010
    Report Date
    May 18, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TRIPLE LUMEN CATHETER WOULD NOT PERFORM CONTINUOUS BLADDER IRRIGATION WITH SEVERAL TRIES. THE CATHETER WAS LEFT IN FOR URINE DRAINAGE. THE CATHETER IS USED FOR CONTINUOUS BLADDER IRRIGATION. IT IS A THREE PORT CATHETER: ONE FOR THE BALLOON, ONE TO ALLOW FLUID TO INSTALL AND ONE TO ALLOW DRAINAGE. THE IRRIGATION FLUID WOULD NOT RUN IN. THE OPERATIVE NOTE CONVEYS THE FOLLOWING: "A 22 THREE-WAY FOLEY CATHETER WAS PLACED INDWELLING, BUT CONTINUOUS IRRIGATION COULD NOT BE ACCOMPLISHED DESPITE VARIOUS EFFORTS. THIS WAS REMOVED, AND UTILIZING A CATHETER GUIDE AGAIN, A 24 FOLEY 3-WAY CATHETER WAS PLACED, A KENDALL POLYETHYLENE BRAND. AGAIN, THIS COULD NOT BE IRRIGATED WITH CONTINUOUS BLADDER IRRIGATION. ULTIMATELY THE URINE WAS CLEAR ENOUGH THAT WE ABANDONED THE CONTINUOUS BLADDER IRRIGATION AND LEFT THE CATHETER IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO/HEALTHCARE CATHETER, FOLEY KOD COVIDIEN * 9082389

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR