BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3843673 · Received March 25, 2014

    Report

    Report Number
    2243969-2014-00127
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. COMPLAINANT HAS CONFIRMED THAT THERE IS NO LOT NUMBER AVAILABLE. IN ADDITION, COMPLAINANT STATED THAT THE ISSUE OCCURRED A WHILE AGO AND COULD NOT NARROW THE TIME FRAME DOWN TO WEEKS OR MONTHS; THEREFORE, NO DATE OF OCCURRENCE WAS PROVIDED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION 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. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. NOTE: 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 INFLATION DIFFICULTIES BASED ON THE INABILITY TO PASS WATER THROUGH THE INFLATION PORT AUTO VALVE RESULTING IN SEVERAL INSERTIONS OF THE FMS. TERRITORY MANAGER PROVIDED INSTRUCTIONS ENSURING THAT THE PISTON ENGAGED FROM LUER LOCK SYRINGE; AUTO VALVE AND BALLOON LEVEL AND THAT AIR WAS FULLY REMOVED. COMPLAINANT REPORTS ALL OF THE SUGGESTED TECHNIQUES WERE ATTEMPTED; HOWEVER, NO WATER WOULD PASS THROUGH INFLATION PORT. A NEW FMS WAS SUCCESSFULLY PLACED INTO THE PATIENT RESULTING IN NO UNTOWARD AFFECT TO THE PATIENT. NO MEDICAL INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173787 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1