BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML

    MDR report key: 17880115 · Received October 5, 2023

    Report

    Report Number
    3013421741-2023-00039
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 5, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    BTT
    UDI-DI
    10190752141643
    PMA / PMN Number
    K853146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. ON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT WHEN THE BOTTLE WAS ATTACHED TO THE OXYGEN WALL, THE WATER BEGAN TO BUBBLE OUT. TWO BOTTLES WITH THE SAME LOT NUMBER HAD THE SAME ISSUE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NOZZLE WHERE THE NASAL CANNULA IS PLACED DOES NOT HAVE A HOLE TO ALLOW OXYGEN TO COME OUT, SO PRESSURE BUILDS UP IN THE 002620 - HUMIDIFIER KIT 500ML 12/CS AND WATER COMES OUT OF THE CONNECTOR ON TOP. THE SAID ISSUE OCCURRED DURING USE ON A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156771 AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT VYAIRE MEDICAL HUMIDIFIER KIT 500ML 12/CS TL2303032 10190752141643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown