BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3813340 · Received March 28, 2014

    Report

    Report Number
    2243969-2014-00138
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 3, 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 SAMPLE WAS AVAILABLE FOR EVALUATION. FINAL QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014 AND AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURER, (B)(4), ON (B)(4) 2014 BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS AND RETAINED SAMPLES. SUMMARY OF THE INVESTIGATION IS AS FOLLOWS: INITIATED DISCREPANCY REPORTS (DR) IN VESTA'S SYSTEM TO CONDUCT AND DOCUMENT INVESTIGATIONS; REVIEWED DEVICE HISTORY RECORDS (DHRS); REVIEWED RETAINED SAMPLES FROM EACH LOT ID IN QUESTION. DURING THE REVIEW OF THE DHRS AND RETAINED SAMPLES, TEAM VERIFIED AND CONFIRMED THAT NO PROCESS DEVIATIONS WERE OBSERVED. THE SUPPLIER CONFIRMED THAT PARTS WERE PROCESSED AT THE SPECIFIED PROCESS PARAMETERS. THE RETAINED SAMPLES WERE REVIEWED AND EXAMINED BY THE SUPPLIER TEAM. IN CONCLUSION, THE SUPPLIER CONFIRMED THAT THE RETAINED SAMPLES MET THE PRODUCT QUALITY SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED FROM THE SUPPLIER. 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, 2243969-2014-00141 RESPECTIVELY. (THIS IS REPORT 2 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. 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
    185393 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES 78 KNT KNT CONVATEC INC. 411107 13VM531214

    Patients

    Seq Age Sex Outcome Treatment
    1