BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3807259 · Received March 20, 2014

    Report

    Report Number
    2243969-2014-00119
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 25, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. IT IS REPORTED THAT SINCE THE PRODUCT WAS PUSHED OUT, IT WAS DISCONTINUED FROM USE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOMES 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

    TERRITORY MANAGER RECEIVED INFORMATION FROM RN WHO REPORTED AS FOLLOWS: A PATIENT WHO PREVIOUSLY HAD A HOLLISTER INSTAFLOW WHICH WAS PLACED IN THE OPERATING ROOM WHILE HE WAS UNDER ANESTHESIA EXPERIENCED LEAKAGE SO THE NURSE REMOVED THE HOLLISTER INSTAFLOW DEVICE AND WENT TO INSERT THE FMS. THERE WERE SEVEN NURSES NEEDED TO POSITION THE PATIENT ON HIS SIDE AS HE WEIGHED (B)(6) LBS. THE NURSE REMOVED THE AIR FROM THE BALLOON AND INSERTED THE FMS DEVICE INTO HIS RECTUM. SINCE THE PATIENT WAS AWAKE, HE WAS BEARING DOWN AS THE NURSE WAS TRYING TO INFLATE THE DEVICE; THEREFORE, IT WAS DIFFICULT FOR HER TO INFLATE THE BALLOON. SHE COULD ONLY INSERT A SMALL AMOUNT OF WATER AT A TIME CONCLUDING WITH A MAXIMUM OF 20 ML. THE PATIENT THEN ENDED UP PUSHING OUT THE BALLOON. THE NURSE OBTAINED ANOTHER KIT AND ATTEMPTED REINSERTION; HOWEVER, THEY EXPERIENCED LEAKAGE FROM THE SECOND FMS INSERTED. NO FURTHER ATTEMPTS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166666 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1