BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3902439 · Received May 7, 2014

    Report

    Report Number
    2243969-2014-00225
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    November 13, 2013
    Report Date
    December 12, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO SAMPLE WAS AVAILABLE FOR EVALUATION. FINAL QUALITY EVALUATION WAS PERFORMED ON (B)(4) /2014 AND AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURER, ON (B)(4) 2014 BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS AND RETAINED SAMPLES. SUMMARY OF THE INVESTIGATION IS AS FOLLOWS: INITIATED DISCREPANCY REPORTS (DR) IN (B)(4)'S SYSTEM TO CONDUCT AND DOCUMENT INVESTIGATIONS; REVIEWED DEVICE HISTORY RECORDS (DHRS); REVIEWED RETAINED SAMPLES FROM EACH LOT ID IN QUESTION. DURING THE REVIEW OF THE DHRS AND RETAINED SAMPLES, TEAM VERIFIED AND CONFIRMED THAT NO PROCESS DEVIATIONS WERE OBSERVED. THE SUPPLIER CONFIRMED THAT PARTS WERE PROCESSED AT THE SPECIFIED PROCESS PARAMETERS. THE RETAINED SAMPLES WERE REVIEWED AND EXAMINED BY THE SUPPLIER TEAM. IN CONCLUSION, THE SUPPLIER CONFIRMED THAT THE RETAINED SAMPLES MET THE PRODUCT QUALITY SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED FROM THE SUPPLIER. PLEASE NOTE: "THIS IS ONE OF FOUR CASES" THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER CASES UNDER PATIENT IDENTIFIER#: (B)(6) AND MFR. REPORT #: 2243969-2014-00217; 2243969-2014-00223 AND 2243969-2014-00224 RESPECTIVELY. (THIS IS REPORT 4 OF 4 TO CAPTURE THESE CASES). NOTE: THIS CASE WAS IDENTIFIED DURING RECENT FDA INSPECTION (483 MARCH/APRIL 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 UPON INSERTION OF PRODUCT INTO PATIENT; THE NURSE WAS UNABLE TO INSTILL MORE THAN 15 ML OF FLUID. THE NURSE WAS UNABLE TO ASPIRATE FLUID OUT RESULTING IN THE NEED TO CUT THE TUBING TO REMOVE THE DEVICE FROM THE PATIENT. DATE OF REMOVAL IS REPORTED AS "UNKNOWN DATE IN (B)(6) 2013". IT IS REPORTED THAT THIS IS ONE (1) OF FOUR (4) CASES; PLEASE SEE (OTHER REMARKS SECTION) FOR RELATED PATIENT IDENTIFIERS AND MFR. REPORT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276779 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 411107 130VM520039

    Patients

    Seq Age Sex Outcome Treatment
    1