BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 3205346 · Received June 28, 2013

    Report

    Report Number
    2243969-2013-00019
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    July 25, 2012
    Report Date
    July 25, 2012
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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]. QUALITY EVAL WAS CONDUCTED BY MFR. BATCH RECORD REVIEW OF THE CATHETERS. REVIEW OF MFG, ASSEMBLY AND PACKAGING PROCESSES AND NON-CONFORMANCES WERE IDENTIFIED. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    COMPLAINT WAS IDENTIFIED IN A WARNING LETTER RECEIVED FROM THE FDA (13-NWJ-08). BALLOON TORE WHILE IN THE ANAL CANAL AND LEAKED FECAL MATTER. THIS CASE WAS REOPENED AND RE-EVALUATED BY THE PRODUCT SAFETY AND REPORTABILITY COMMITTEE. AS A RESULT, THE MEDICAL DETERMINATION IS BEING CHANGED TO REPORTABLE MALFUNCTION. THE COMPLAINT NARRATIVE DESCRIBED A MALFUNCTION (A LEAKAGE) THAT LED TO FECAL LEAKAGE. IT IS UNK 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 HOSP SETTINGS WHERE THESE DEVICES ARE USED, THE STANDARD CLINICAL PRACTICE IS TO COVER ANY WOUNDS WITH APPROPRIATE BARRIER DRESSINGS TO FACILITATE HEALING AND TO FURTHER REDUCE THE RISK OF FECAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295863 FLEXI-SEAL FMS GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC NA 08TM03

    Patients

    Seq Age Sex Outcome Treatment
    1