BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4121553 · Received July 29, 2014

    Report

    Report Number
    1049092-2014-00353
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 8, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, AS NONE OF THE DEVICES ATTEMPTED TO USE REACHED THE PT OR WERE INSERTED INTO PTS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. PLEASE NOTE: THERE ARE THREE (2) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. REPORTED TO FDA ON JULY 28, 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 THE FIRST INCIDENT OCCURRED WHILST THE BOWEL MANAGEMENT SYSTEM WAS INSITU AND THE IRRIGATION/INFLATION PORT TUBES FROM CAME AWAY FROM THE MAIN SYSTEM, ANOTHER SET WAS PREPARED AND THE SAME PROBLEM OCCURRED AGAIN; HOWEVER, THIS TIME IT HAD NOT BEEN INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442816 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1