BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3950730 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00178
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FMS BALLOON WOULD NOT DEFLATE WHILE ATTEMPTING TO DEFLATE THE BALLOON IN ORDER TO REMOVE THE FMS FROM PATIENT. IT IS ALSO REPORTED THAT THE INDICATOR PORT HAD A SMALL BUBBLE THAT IS IN THE RISE POSITION. A SYRINGE WAS REATTACHED, BUT THE BALLOON WOULD STILL NOT DEFLATE. LASTLY, COMPLAINANT WAS ADVISED TO CUT THE INFLATION LINE TO LET THE WATER DRAIN FROM THE BALLOON. THE DEVICE WAS REPLACED, AND A NEW DEVICE WAS REINSERTED WITHOUT DIFFICULTY. IT IS REPORTED THAT PRODUCT WAS IN USE FOR TWO (2) DAYS BEFORE THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334988 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 418000 13-FM-0217

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR