BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3902455 · Received May 7, 2014

    Report

    Report Number
    2243969-2014-00227
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THIS IS ALL INFORMATION AVAILABLE. LOT NUMBER IS NOT AVAILABLE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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 OF THE FMS, NURSE INSTILLED BETWEEN 35-40 MLS OF FLUID AND WITHIN A MINUTE IT BEGAN TO LEAK OUT OF THE INFLATION PORT, RESULTING IN THE BALLOON TO SLID OUT OF THE PATIENT'S RECTAL VAULT. A NEW DEVICE WAS INSERTED AND IT FUNCTIONED WELL. NO UNTOWARD EFFECTS TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276833 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC, INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1