MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; HUMIDIFICATION SYSTEM, COMFORT FLO

Catalog Number	HUD2410
Medical Device Problem Codes	Leak/Splash (1354); Increase in Pressure (1491)
Health Effect - Clinical Codes	Choking (2464); Low Oxygen Saturation (2477); Cough (4457)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".
Additional Manufacturer Narrative
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).

• Brand Name: MEDLINE
• Common Device Name: HUMIDIFICATION SYSTEM, COMFORT FLO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 23865321
• Report Number: 1417592-2025-00733
• Device Sequence Number: 17255975
• Product Code: BTT
• UDI-Device Identifier: 10197344009589
• UDI-Public: 10197344009589
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HUD2410
• Device Lot Number: 24I0A690, 24L0A197, 25A0A623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male