BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGELLAN SPRAY TIP

    MDR report key: 1636004 · Received March 12, 2010

    Report

    Report Number
    2183425-2010-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Report Date
    March 12, 2010
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    KYZ
    PMA / PMN Number
    K883338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAINTENANCE ACTIVITY ON (B)(4)-2010 RESULTED IN THE THERMOCOUPLE ON THE HEAT SEALER (B)(4) TO BE INCORRECTLY MOUNTED RESULTING IN A POSSIBLE POOR SEAL IF THE POUCH WAS NOT PLACED DIRECTLY UNDER THE THERMOCOUPLE LOCATION WHEN SEALING A PAIR OF POUCHES. THE SEALER WAS NOT REVALIDATED AFTER THE MAINTENANCE FOR MANUFACTURING ENGINEER DETERMINED IT WAS NOT NECESSARY BECAUSE THE THERMOCOUPLE WAS NOT REPLACED. PRIOR TO THE MAINTENANCE OF (B)(4)-2010 POUCH LOCATION ON THE SEALING BAR WAS NOT A CRITICAL SEALING PARAMETER. ONLY TWO STYLES OF POUCHES ARE SEALED AS A PAIR AND WERE AFFECTED. CORRECTIVE ACTION: ALL SHIPMENTS OF PRODUCT WERE STOPPED ON (B)(4)-2010. ALL HEAT SEALING ON HEAT SEALER (B)(4) WAS STOPPED ON (B)(4)-2010). ONE HUNDRED PERCENT BLACKLIGHT INSPECTION OF LOTS PRIOR TO AND AFTER THE IDENTIFIED PRODUCT LOT# WAS PERFORMED. INSPECTION RESULTS VERIFIED THERE WERE NO POOR SEALS PRIOR TO (B)(4)-2010 AND THAT THE POOR SEALS WERE ISOLATED TO ONLY THE 2 POUCH STYLES FOR THESE WERE THE ONLY POUCHES THAT WERE SEALED AS A PAIR. THE HEAT SEALER (B)(4) WAS SERVICED ON (B)(4)-2010 AND THE THERMOCOUPLE WAS FOUND TO BE IMPROPERLY MOUNTED. THE THERMOCOUPLE WAS REPLACED AND MOUNTED CORRECTLY. THE HEAT SEALER (B)(4) HAS BEEN REVALIDATED WITH BURST TESTING, PEEL TESTING AND BLACKLIGHT INSPECTION ON (B)(4)-2010. THE HEAT SEALER (B)(4) WAS RETURNED TO PRODUCTION ON (B)(4)-2010 WITH 100% BLACK LIGHT INSPECTION OF THE SEAL. THE SEALER (B)(4) WAS NOT REVALIDATED ON (B)(4)-2010 FOR THE THERMOCOUPLE WAS NOT REPLACED. FUTURE SEALER MAINTENANCE ACTIVITIES WILL REQUIRE EQUIPMENT REVALIDATION PRIOR TO RELEASING TO PRODUCTION. THE SEALER REVALIDATION PROCEDURE HAS BEEN UPDATED TO DETERMINE THE OPTIMUM TEMPERATURE SEALING WITH THE USE OF BLACKLIGHT, BURST TESTING AND PEEL TESTING ON ALL SIZES OF POUCHES.

    Description of Event or Problem · 1

    POOR MANUFACTURING STERILIZATION BARRIER SEAL. INITIAL OPEN SEAL WAS OBSERVED IN INVENTORY ON (B)(6)-2010. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGELLAN SPRAY TIP DUAL SPRAY KYZ MICROMEDICS, INC. 113511

    Patients

    Seq Age Sex Outcome Treatment
    1