BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML

    MDR report key: 18145419 · Received November 15, 2023

    Report

    Report Number
    3013421741-2023-00046
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 15, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BTT
    UDI-DI
    10190752141643
    PMA / PMN Number
    K853146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, G6, H2, H3, H6 AND H10 . RESULT OF INVESTIGATION: DUE TO THE UNAVAILABILITY OF PHOTOGRAPHS, SPECIFIC QUANTITIES OF THE AFFECTED MATERIAL, AND SAMPLES AVAILABLE FOR EVALUATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE RESULTS OF THE FUNCTIONAL TESTS, PIVOT OPENING, TIGHTNESS, THICKNESS MONITORING, BOTTLE SEAL DIAMETER AND THICKNESS MONITORING, BACKPRESSURE OPENING, AND STATISTICAL INSPECTIONS BY STAGE, AS WELL AS EACH OF THE REJECTIONS DUE TO DEFECTIVE ITEMS IDENTIFIED AND SEGREGATED DURING PRODUCT MANUFACTURING, ARE AVAILABLE. TEST RESULTS COMPLY WITH VALIDATED PARAMETERS AND PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 002620 - HUMIDIFIER KIT 500ML 12/CS WAS SO FULL THAT BUBBLES BACKED UP TO THE TUBING AND WATER BACKED UP IN THE CANNULA. ALSO, THE TUBING FOR OXYGEN WAS BEING FILLED WITH WATER, AND WATER DRIPS INTO THE NOSE OF THE PATIENT AND INTO THE CANNULA. THE PATIENT'S STATUS IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197783 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VYAIRE MEDICAL HUMIDIFIER KIT 500ML 12/CS TL2212106 10190752141643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown