BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3853554 · Received April 3, 2014

    Report

    Report Number
    2243969-2014-00173
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    January 13, 2014
    Report Date
    March 12, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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. DUE TO THE NATURE OF THE PRODUCT THE SITE WAS NOT ABLE TO RETAIN THE DEVICES. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. PLEASE NOTE: EVENT DESCRIPTION REFERENCES "FOUR (4) DEVICES FAILED TO INFLATE; ALL WITH SAME LOT NUMBER" THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER THREE (3) CASES UNDER (B)(6) RESPECTIVELY. 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

    COMPLAINT REPORTED OF FAILED ATTEMPTS TO INFLATE BALLOON END WITH WATER. THIS OCCURRED ON FOUR (4) DIFFERENT FLEX-SEAL DEVICES OVER THE LAST THREE (3) DAYS. IT IS REPORTED THAT FOUR (4) DEVICE FAILED TO INFLATE; ALL WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202602 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 13VM521749

    Patients

    Seq Age Sex Outcome Treatment
    1