BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3851647 · Received April 18, 2014

    Report

    Report Number
    2243969-2014-00192
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CONVATEC
    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 WAS NO REPORT OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO 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. 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 FLUID BEGAN TO COME OUT OF THE BALLOON AND EXPELLED OUT OF THE PT'S RECTAL VAULT. THE SAME DEVICE WAS REINSERTED AND IT WOULD NOT INFLATE. THE DEVICE WAS REMOVED FOR A SECOND TIME AND THE NURSE TRIED TO INFLATE WHILE OUTSIDE THE PT. IT DID NOT. THE DEVICE WAS DISCARDED AND REPLACED WITH ANOTHER UNIT AND THIS ONE FUNCTIONED PROPERLY. NO UNTOWARD EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238512 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES 78KNT KNT CONVATEC 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1