BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3950729 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00179
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. ON THE COMPLAINT FORM IN THE DETAILS OF COMPLAINTS BOX THE PRINT IS VERY SMALL AND PARTS OF THE INFORMATION IS ILLEGIBLE. THE ANSWER TO THE QUESTION "HOW LONG WAS THE PRODUCT IN USE BEFORE THE EVENT OCCURRED" IS ANSWERED IN VERY SMALL ILLEGIBLE PRINT SO CNO WAS CHOSEN; THEREFORE AN EMAIL WAS SENT REQUESTED CLARITY OF THE COMPLAINT DESCRIPTION AND THE ANSWER TO THIS QUESTION: HOW LONG WAS THE PRODUCT IN USE BEFORE THE EVENT OCCURRED." NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. 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 IN FILLING THE CUFF. REPORT STATES "IN THE BEGINNING IT WAS IMPOSSIBLE TO FILL THE CUFF. AIR WAS REMOVED FROM THE CUFF BEFORE THE SYSTEM WAS PLACED IN THE PATIENT'S RECTUM THE TUBE WAS INSPECTED AND DID NOT KINK IN ANY WAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334336 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 13VM523336

    Patients

    Seq Age Sex Outcome Treatment
    1