BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 3205367 · Received June 28, 2013

    Report

    Report Number
    2243969-2013-00018
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE RECEIPT OF AN FDA WARNING LETTER (13-NWJ-08), THIS CASE WAS REOPENED AND RE-EVALUATED BY THE (B)(4). THE COMPLAINT NARRATIVE DESCRIBED A MALFUNCTION (A LEAKAGE) THAT LED TO FECAL LEAKAGE. IT IS UNKNOWN IF PT HAD A WOUND IN THE GENERAL AREA. ALTHOUGH THE RISK OF WOUND CONTAMINATION BY FECAL MATTER IS GREATLY REDUCED WITH THE USE OF THE FMS DEVICE WHEN COMPARED WITH OTHER METHODS, THE POSSIBILITY OF CONTAMINATION AND WOUND INFECTION CANNOT BE COMPLETELY RULED OUT. THE PRODUCT INSERT UNDER PRECAUTIONS AND OBSERVATIONS WARNS END USERS TO PROVIDE FOR SKIN CARE AND INTERVENTIONS AS SOME LEAKAGE OF STOOL AROUND THE DEVICE IS TO BE EXPECTED. IN THE HOSPITAL SETTINGS WHERE THESE DEVICES ARE USED, THE STANDARD CLINICAL PRACTICE IS TO COVER AND WOUNDS WITH APPROPRIATE BARRIER DRESSINGS TO FACILITATE HEALING AND TO FURTHER REDUCE THE RISK OF FECAL CONTAMINATION. AS OF (B)(4) 2013 THE CUSTOMER HAS NOT PROVIDED THE LOT NUMBER OF THE PRODUCT. SINCE THE BALLOON WAS TORN APART AND THE BALLOON CUFF WAS BROKEN IN THIS RETURNED CATHETER, THERE WAS NOTHING FURTHER THAT COULD BE EXAMINED RELATED TO THE LAB EVALUATION. VISUAL INSPECTION WAS CONDUCTED. INFLATION PORT AND IRRIGATION PORT WERE CONFIRMED TO BE PRESENT. IT WAS OBSERVED THAT THERE WAS A COHESIVE FAILURE IN THE ADHESIVE BETWEEN BALLOON AND THE CATHETER. THIS OBSERVATION CONFIRMED THAT THE ADHESIVE WAS PRESENT; HOWEVER, THE COHESIVE FAILURE OBSERVATION IS NOT ASSOCIATED WITH THE ROOT CAUSE OF THE COMPLAINT. THE ROOT CAUSE FOR THE TEAR IN THE BALLOON IS UNKNOWN AT THIS TIME. WE WILL CONTINUE THE INVESTIGATION AND MONITOR FOR SIMILAR COMPLAINTS WITH THIS ISSUE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT WAS IDENTIFIED IN A WARNING LETTER RECEIVED FROM THE FDA (13-NWJ-08). THE BALLOON WAS INSERTED AND USED FOR A WEEK AND THEN LOST WATER AND LEAKAGE WAS DISCOVERED. ON THE BASIS OF THE RE-EVALUATION OF THIS CASE, FOLLOWING THE RECEIPT OF WARNING LETTER 13-NWJ-08, THIS CASE IS DEEMED TO BE A REPORTABLE MALFUNCTION. [AS THE POTENTIAL FOR A SERIOUS INJURY CANNOT BE RULED OUT IF THE MALFUNCTION WERE TO RECUR].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295264 FLEXI-SEAL SIGNAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1