BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3813339 · Received March 28, 2014

    Report

    Report Number
    2243969-2014-00141
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 2, 2014
    Report Date
    March 3, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. PLEASE NOTE: EVENT DESCRIPTION REFERENCES "THREE (3) KITS FAILED" THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER 2 CASES UNDER (B)(6), AND MFR REPORTS: 2243969-2014-00137, 2243969-2014-00138 RESPECTIVELY. (THIS IS REPORT 3 OF 3 TO CAPTURE THESE CASES). 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

    FLOOR NURSE REPORTED THAT SHE EXPERIENCED INFLATION DIFFICULTIES BASED ON THE INABILITY TO INFLATE THE FMS BALLOON PAST 10CC WHILE THE DEVICE WAS INSTILLED IN THE PATIENT, WHICH REQUIRED REMOVAL AND INSERTION OF TWO OTHER FMS KITS BUT THOSE FAILED AS WELL. IT IS REPORTED THAT THE TERRITORY MANAGER WENT OVER TO TROUBLESHOOT THE ISSUE, AND STILL INFLATION FAILED. TERRITORY MANAGER IS SENDING REPLACEMENTS. IT IS REPORTED THAT THREE KITS FAILED, TWO WITH THE SAME LOT NUMBER, AND A THIRD WITH A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184797 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES 78 KNT KNT CONVATEC INC. 411107 13VM528992

    Patients

    Seq Age Sex Outcome Treatment
    1