BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS

    MDR report key: 3915436 · Received February 25, 2014

    Report

    Report Number
    2243969-2014-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 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 WER NO REPOTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. IT IS ALSO REPORTED THAT THE RECTAL TUBES WERE UNABLE TO BE SAVED SINCE THE STAFF FELT THAT THEY WER CONTAMINATED AND SHOULD NOT BE SAVED. NO SAMPLE WAS AVAILABLE FOR EVALUATION. FINAL QUALITY EVALUATION WAS PERFORMED ON 02/13/2014 AND AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MFR, (B)(4), ON 02/12/2014 BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS AND RETAINED SAMPLES. SUMMARY OF THE INVESTIGATION IS AS FOLLOWS: REVIEWED DEVICE HISTORY RECORDS (DHR'S). REVIEWED RETURNED SAMPLES FROM EACH LOT ID IN QUESTION. DURING THE REVIEW OF THE DHR'S 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. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC'S INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NO ADDITIONAL INFO IS EXPECTED.

    Description of Event or Problem · 1

    INFO RECEIVED VIA EMAIL IS INDICATED AS FOLLOWS: "WHEN PLACING RECTAL TUBE FOR PT - WE ENDING UP USING 3 RECTAL TUBES SINCE THE FIRST TWO WERE DEFECTIVE. THERE WAS A HOLE DIRECTLY ABOVE THE "AUTOFILL VALVE" SO AFTER YOU INSTILL THE WATER - WHEN YOU UNHOOK THE SYRINGE, THE WATER WOULD "SHOOT OUT" OF THIS RANDOM HOLE - BOTH TUBES DEFECTIVE. THE 3RD TUBE WORKED AND NO HOLE ABOVE THE VALVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115724 FLEXI-SEAL CONTROL FMS GASTROINTESTINAL TUBE AND ACCESSORIE, 78 KNT KNT CONVATEC INC 411107 13VM528992

    Patients

    Seq Age Sex Outcome Treatment
    1