BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML (LINDEN LUER)

    MDR report key: 1931815 · Received November 30, 2010

    Report

    Report Number
    9610849-2010-00017
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: YES. POOR SEALING OCCURRED WHEN THE CYCLE OF THE SEALING MACHINE WAS INTERRUPTED. CONCLUSIONS: DEVICE HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON CONFORMANCE REPORTS GENERATED DURING THE MFG OF THIS LOT NUMBER. ONE RETURNED SAMPLE DID NOT HAVE A COMPLETE SEAL. INVESTIGATION SHOWS THE POOR SEALING OCCURRED WHEN THE SEALING CYCLE WAS INTERRUPTED. DURING THIS INTERRUPTION, THE COMPONENTS (TRAY AND TYVEK LID) WERE AFFECTED AND PROPER SEALING DID NOT OCCUR. CORRECTIVE ACTIONS: AS CONTAINMENT, AN INSPECTION POINT WAS ADDED AT THE END OF THE ASSEMBLY PROCESS TO ASSURE PROPER SEALING OF THE PRODUCT. A VISUAL AID IS GOING TO BE GENERATED ON STEPS TO PERFORM WHEN THE CYCLE OF THE MACHINE IS INTERRUPTED. AN AUTOMATIC SYSTEM IS GOING TO BE IMPLEMENTED TO PULL OUT QUESTIONABLE MATERIAL WHEN THE CYCLE OF THE MACHINE IS INTERRUPTED.

    Description of Event or Problem · 1

    (B)(4) DISTRIBUTOR REPORTS VIA E-MAIL, WE FOUND AT INCOMING INSPECTION THAT THE SUBJECT PRODUCTS HAVE INCOMPLETE STERILIZE SEALING. NO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML (LINDEN LUER) DISPOSABLE EMPTY SYRINGE DXT COVIDIEN ILLUMENA 150ML 0253305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK