BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE

    MDR report key: 23865321 · Received December 22, 2025

    Report

    Report Number
    1417592-2025-00733
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 19, 2025
    Report Date
    April 8, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    BTT
    UDI-DI
    10197344009589
    PMA / PMN Number
    K131912
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D9: DEVICE AVAILABLE FOR EVALUATION AND DATE RETURNED TO MANUFACTURER. UPDATED H3: DEVICE EVALUATED BY MANUFACTURER. UPDATED H6: INVESTIGATION FINDINGS (C). UPDATED H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, ON 11/19/2025, WHEN PATIENT WAS USING COMFORT FLOW HUMIDIFICATION SYSTEM, THERE WAS A "SUDDEN BURST OF WATER AND PRESSURE" AND THE "PATIENT STARTED CHOKING AND COUGHING AS WATER SPRAYED IN FACE." THE NURSE "REMOVED THE PATIENT FROM THE HHFNC AND PLACED ON 15 LPM NRB." THE PATIENT'S OXYGEN SATURATION "DROPPED TO 60%, PT RECOVERED AFTER 3 MINUTES." THE FACILITY STATED THE UNIT "TUBING WAS FULL OF WATER." THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MANUFACTURING DATES FOR REPORTED LOT NUMBERS: 24I0A690- 09/2024, 24L0A197-12/2024, 25A0A623-01/2025. EXPIRATION DATES FOR REPORTED LOT NUMBERS: 24I0A690- 09/2029, 24L0A197-12/2029, 25A0A623-01/2030.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, WHEN PATIENT WAS USING COMFORT FLOW HUMIDIFICATION SYSTEM, THERE WAS A "SUDDEN BURST OF WATER AND PRESSURE" AND THE "PATIENT STARTED CHOKING AND COUGHING AS WATER SPRAYED IN FACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183992 MEDLINE HUMIDIFICATION SYSTEM, COMFORT FLO BTT MEDLINE INDUSTRIES, LP 24I0A690, 24L0A197, 25A0A623 10197344009589

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other