MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; O2 MASK,MED CONC,ADULT,7' TUB UC

Catalog Number	HUD1930
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tubing to the mask was disconnected.Very loose fitting.Tubing that connects to base of mask came dislodged.".
Additional Manufacturer Narrative
The customer reported the patient was on a 6-liter simple mask, sats were noticed to be 88%, and the tubing to the mask was disconnected, very loose fitting, and tubing that connects to base of mask came dislodged.No sample or photo was received for the investigation; review of the previous trend reports was completed for trending purposes, and trends were identified.The reported problem could not be evaluated by sample or photo.The root cause of the reported issue was determined to be reduced strength of the connection point due to a material change, and the root cause of the recall was a material change that weakened the connection between the grommet of the medium concentration mask and the female adaptor; if additional information becomes available, the complaint will be reopened, updated, and investigated as necessary.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: O2 MASK,MED CONC,ADULT,7' TUB UC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50498303
• Report Number: 1417592-2026-26916
• Device Sequence Number: 9460091
• Product Code: BYG
• UDI-Device Identifier: 10197344009626
• UDI-Public: 10197344009626
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: HUD1930
• Device Lot Number: 25FOA650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female