BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3810673 · Received March 24, 2014

    Report

    Report Number
    2243969-2014-00123
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 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 INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO SAMPLE WAS AVAILABLE FOR EVALUATION. FINAL QUALITY EVALUATION WAS PERFORMED ON 03/18/2014 AND AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MFR, (B)(4), ON 03/17/2014 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) 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. TWO DEVICES FROM DIFFERENT LOTS FAILED TO HOLD WATER; THEREFORE; A SEPARATE 3500A FORM HAS BEEN COMPLETED UNDER PT IDENTIFIER#: (B)(4) AND MFR REPORT #: 2243969-2014-00124. (B)(4). 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 THE FMS BALLOON WOULD NOT HOLD WATER, THE SYRINGE WAS ATTACHED WHEN ATTEMPTING TO INSERT WATER INTO THE BALLOON. THE DEVICE WAS REMOVED FROM THE PT. ADDITIONAL INFO RECEIVED FROM THE COMPLAINANT ON (B)(6) 2014 VIA VOICEMAIL REPORTING NO NEW DEVICE INSERTED AFTER FIRST TWO FAILED. NO UNTOWARD EFFECT TO PT FROM AFFECTS OF TWO DEVICES DIFFERENT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172556 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 411107 13VM528992

    Patients

    Seq Age Sex Outcome Treatment
    1