BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MM10 SVN W/ADULT MASK & 7FT TBG 50/CS

    MDR report key: 2991111 · Received March 6, 2013

    Report

    Report Number
    8030673-2013-00032
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 14, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CAF
    PMA / PMN Number
    K023602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THIS DEVICE IS IN PROCESS. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION, WE CONFIRMED THAT THE MISTY MAX BOTTOM OF THE SAMPLE WAS COMPLETELY OCCLUDED. THE PRODUCTION RECORD FOR THE LOT NUMBER REPORTED WAS EVALUATED AND NO ISSUES WERE OBSERVED. THE POSSIBLE ROOT CAUSE OF THE REPORTED ISSUE IS THAT OUR MOLDING EQUIPMENT HAS THE CORE PIN DAMAGED. A DAMAGED CORE PIN MAY CAUSE THE MISTY MAX BOTTOM STEM TO BE OCCLUDED. AS AN ACTION PLAN, THE PERSONNEL WERE NOTIFIED OF THIS PROBLEM. IN ADDITION, THE QUALITY PERSONNEL WILL IMPROVE THE PRODUCTION OF THE RUN OF THE MOLD AND THE INSPECTION PROCESS. IN ANY FUTURE OCCURRENCES, IF A PRODUCTION ERROR IS NOTED, THE OPERATOR WILL FOLLOW THE PROCEDURE OF A PRODUCTION HALT UNTIL THE ISSUE IS RESOLVED INCLUDING A 100% QUALITY CHECK OF REPRESENTATIVE SAMPLES PRODUCED WITH THE MOLD IN QUESTION TO ASSURE THAT NO AFFECTED PRODUCT IS RELEASED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: AIR DOES NOT FLOW THROUGH THE AEROSOL CHAMBER. WHEN THE AIR WAS TURNED ON, THE PRESSURE "POPPED" THE TUBING OFF THE NEBULIZER. TWO SAMPLES AVAILABLE, TO FOLLOW. NO PATIENT INCIDENT. NOTICED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95046 MM10 SVN W/ADULT MASK & 7FT TBG 50/CS NEBULIZER (DIRECT PATIENT INTERFACE) CAF CAREFUSION 002433-A 0000444741

    Patients

    Seq Age Sex Outcome Treatment
    1