BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4200272 · Received October 22, 2014

    Report

    Report Number
    1049092-2014-00557
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THAT THE CUSTOMER COMPLAINED "IN THIS SITUATION THE PATIENT MAY NEED TO GO THROUGH A SURGERY." PHOTOGRAPHS WERE PROVIDED TO AID IN THE ONGOING INVESTIGATION. THE DEVICE WAS RETURNED TO THE CONVATEC SALES REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE ARE TWO CASES ASSOCIATED WITH THIS EVENT; THEREFORE AN ADDITIONAL FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER CASE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 08/11/2015. THIRD PARTY MFR REVIEWED THE ROUTERS USED TO MANUFACTURE LOT #12VM471622 AND NO DEVIATIONS OR DISCREPANCIES WERE NOTED. IT WAS DETERMINED THE LOT WAS MANUFACTURED WITHOUT INCIDENT. THE RETAINED SAMPLES FOR THIS LOT WERE INSPECTED AND WERE FOUND TO BE FUNCTIONAL AND NON-DEFECTIVE. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH BATCH 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.

    Description of Event or Problem · 1

    IT IS REPORTED THE DEVICE WAS INSERTED INTO THE PATIENT'S ANUS AND THE BALLOON INFLATED, HOWEVER WHEN THE CUSTOMER TRIED TO DEFLATE THE BALLOON THE AIR DID NOT COME OUT. THE BALLOON WAS DEFLATED AFTER GOING THROUGH CHALLENGING TRIALS AND IT EVENTUALLY WAS REMOVED FROM THE PATIENT. AT THAT POINT, THE CUSTOMER TRIED BALLOON TESTING OF THE PRODUCT THROUGH WATER, HOWEVER, THE SAME ISSUE OF BALLOON DEFLATION FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673732 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT TUBES, GASTROINTESTINAL KNT CONVATEC, INC 411100 12VM471622

    Patients

    Seq Age Sex Outcome Treatment
    1