BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MGMT SYSTEM KIT

    MDR report key: 3952968 · Received May 20, 2014

    Report

    Report Number
    1049092-2014-00127
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 4, 2014
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 15, 2015. THIRD PARTY MANUFACTURER PERFORMED A BATCH RECORD REVIEW FOR LOT NUMBER 13FM0216C AS WELL AS THE RETENTION SAMPLES AND NO DISCREPANCIES WERE FOUND. ONE SAMPLE WAS TESTED WITH AIR - 60 ML FOR 10 MINUTES AND WATER - 45ML FOR 24 HOURS. FIVE OTHER SAMPLES FROM OTHER LOTS WERE ALSO TESTED AND NO ISSUES WERE NOTED DURING INFLATION, RETENTION AND DEFLATION. AFTER A THOROUGH BATCH RECORD REVIEW NO DISCREPANCIES OR NON-CONFORMANCES WERE DISCOVERED. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JULY 13, 2015.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO REPORT OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS REPORTED THAT THE PRODUCT WAS NOT USED ON PT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THIS CASE IS RELATED TO PT IDENTIFIER #: (B)(6)REPORTED UNDER MFR'S REPORT #: 1049092-2014-00127. 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 UPON OPENING A FMS PRODUCT FOR SUE ON PT, PRIOR TO INSERTION A TEAR WAS NOTICED IN THE BALLOON. IT IS REPORTED THAT AN ADDITIONAL PRODUCT WAS TAKEN OFF THE SHELF FOR USE WHICH EXPERIENCED DEFLATION DIFFICULTIES AFTER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298941 FLEXI-SEAL SIGNAL FECAL MGMT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC 418000 13FM0216C

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR