BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3810659 · Received March 24, 2014

    Report

    Report Number
    2243969-2014-00122
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS REPORTED THAT THE TERRITORY MANAGER WAS NOTIFIED AND A REPLACEMENT DEVICE SENT. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. FDA REGISTRATION NUMBER. (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO IT'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    NURSE REPORTED THAT HE WAS UNABLE TO INFLATE BALLOON UPON INSERTION. ANOTHER UNIT WAS USED AND WAS SUCCESSFUL WITH THE SECOND UNIT. IT IS REPORTED THAT HE NOTICED LEAKAGE AT THE AUTO VALVE WITH FILL INDICATOR. NO UNTOWARD EFFECT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172845 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES, 78 KNT KNT CONVATEC, INC. 411107 14VM531935

    Patients

    Seq Age Sex Outcome Treatment
    1