BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-SEAL FMS FECAL MGMT SYS KIT

    MDR report key: 3915423 · Received February 25, 2014

    Report

    Report Number
    2243969-2014-00047
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 INDICATION FOR USE WAS NO LONGER RELEVANT. AN EMAIL REQUEST WAS SENT ON (B)(4) 2014 REQUESTING FURTHER INFO. FINAL QUALITY EVALUATION WAS PERFORMED ON 02/21/2014 AND AN INVESTIGATION WAS PERFORMED BY THE SUPPLIER, (B)(4), ON 02/17/2014 BASED ON THE REVIEW OF THE QC RECORD AND RELATED LOT. SUPPLIER REVIEWED THE QC RECORD FOR THE RELATED LOT AND FOUND NO EXCEPTIONAL RECORDS. ALSO THE SUPPLIER TESTED SEVERAL RETENTION SAMPLED FROM RELATED LOT AND RESULTS SHOWED THAT BALLOON APPEARANCE, CATHETER BODY AND VALVE FUNCTIONS ARE NORMAL. RESULTS OF THE INVESTIGATION IS AS FOLLOWS: IF DURING THE PROCESS THE BALLOONS FAILED TEST IT WILL BE DETECTED AND PRODUCT STOPPED; IF SYRINGE IS NOT FULLY CONNECTED THE BALLOON CANNOT BE FULLY INFLATED OR DEFLATED; DEFECTIVE SITUATION MIGHT NOT BE KNOWN DUE TO SAMPLE WAS NOT RETURNED. IN CONCLUSION, NO CORRECTIVE ACTIONS COULD BE MADE WITHOUT RETURNED PRODUCT PARTS ARE RANDOMLY INSPECTED AT INCOMING INSPECTION AND TEST PERFORMED DURING THE MANUFACTURING PROCESS. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADDITIONAL INFO IS EXPECTED.

    Description of Event or Problem · 1

    INFO RECEIVED VIA COMPLAINT FORM IS INDICATED AS FOLLOWS: "FLEXI-SEAL SIGNAL COULD NOT BE REMOVED FROM PT WITHOUT CUTTING THE SYSTEM, AS THE WATER IN THE CUFF COULD NOT BE WITHDRAWN. IT WAS NOT POSSIBLE TO FILL MORE FLUID IN THE CUFF EITHER. SYSTEM WAS COMPLETELY LOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116081 FLEX-SEAL FMS FECAL MGMT SYS KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC 418000 13-FM-0206

    Patients

    Seq Age Sex Outcome Treatment
    1