BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3813359 · Received March 28, 2014

    Report

    Report Number
    2243969-2014-00143
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. LOT NUMBER UNKNOWN AS KIT WAS DISCARDED. COMPLAINANT HAS CONFIRMED THAT PRODUCT LOT NUMBER IS NOT AVAILABLE AND NOT ABLE TO BE RETRIEVED. IT IS REPORTED THAT AT THIS TIME THE FACILITY HAS DISCONTINUED USE OF THE 411107 (FMS CONTROL) AND HAS RETURNED TO THE USE OF THE 418000 (FMS SIGNAL). IT IS ALSO REPORTED THAT AT THIS TIME THE FACILITY PLANS TO CONTINUE USE OF 418000 (FMS SIGNAL) UNTIL ADDITIONAL IN-SERVICING IS COMPLETED. TROUBLESHOOTING RECOMMENDATIONS WERE REVIEWED BY CONVATEC AS FOLLOWS: ASSURING THAT THE SYRINGE IS SECURELY ENGAGED AND DEPRESSING THE BLACK PISTON; ASSURING THAT THE TUBING FROM THE PROT TO THE CATHETER IS NOT TWISTED AND THAT THE BALLOON IS AT THE SAME LEVEL AS THE PORT. 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. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. PLEASE NOTE: EVENT DESCRIPTION REFERENCES "THIS ISSUE OCCURRED ON THREE (3) SEPARATE CASES" THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER 2 CASES UNDER (B)(6) AND MFR REPORTS 2243969-2014-00142 AND 2243969-2014-00144 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

    IT IS REPORTED THAT COMPLAINANT EXPERIENCED DIFFICULTIES BASED ON THE INABILITY TO INFLATE THE FMS BALLOON AND WAS ABLE TO INSTILL APPROXIMATELY ONE-HALF OF FLUID AND LEAKAGE OCCURRED AROUND THE TUBING NECESSITATING PRODUCT TO BE REMOVED. MALFUNCTIONED KIT REMOVED AND REPLACED RESULTING IN NO HARM TO THE PATIENT. IT IS REPORTED THAT THIS ISSUE OCCURRED ON THREE (3) SEPARATE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185507 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES 78 KNT KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1