BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT PREFILL NEB W NEB CAP STERILE WATER

    MDR report key: 6677008 · Received June 29, 2017

    Report

    Report Number
    8030673-2017-00348
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 29, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGG
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ¿WE HAD A SERIOUS SAFETY EVENT WHERE WE CONNECTED THE AEROSOL TO THE FLOWMETER, ADDED THE BLUE CORRUGATED TUBING WITH A DRAIN BAG, AND THEN ATTACHED THE OTHER END OF THE BLUE CORRUGATED TUBING TO AN IN-LINE SUCTION DEVICE THAT WAS CONNECTED TO THE ENDOTRACHEAL TUBE. WE NEEDED TO DELIVER 100%, SO WE TURNED THE DIAL TO 100% AND SET THE FLOWMETER TO 12 LITERS/MINUTE. THE CAP ON THE END OF THE SUCTION DEVICE WASN¿T REMOVED AND QUICKLY WITHIN 2-3 SECONDS THE PATIENT HAD EXCESSIVE PRESSURE/VOLUME BUILD-UP INSIDE THE LUNGS DUE TO THE CLOSED-SYSTEM. WITH THIS SET-UP, EVERY SECOND THERE IS 200 ML OF FLOW, SO IN 3 SECONDS TIME THERE WAS 600 ML OF VOLUME DELIVERED TO THE PATIENT¿. CUSTOMER REPORTED THE INLINE SUCTION PRODUCT WITH THE CAP IS CODE 220579 THIS IS A HALYARD PRODUCT THEY HAVE BEEN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457492 KIT PREFILL NEB W NEB CAP STERILE WATER HUMIDIFIER NEBULIZER KIT OGG VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention