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

Catalog Number	HUD1930
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the tubing is very easily disconnecting from the mask, leaving the patient without oxygen and making them re-breathe co2.¿.
Additional Manufacturer Narrative
The account reported multiple incidents where the tubing falls off the mask, the tubing is not well seated onto the mask and comes off easily; no serious injury, no medical intervention, no follow-up care, and no impact to the patients was reported.A photo and a sample were received, and the sample was received out of its original packaging with the tubing visually observed to be disconnected from the mask; visual evaluation did not observe any damage, defects, or foreign matter within the tubing/mask connection.The reported problem was confirmed based on the tubing being visually observed to be disconnected from the mask.The root cause of the reported issue was determined to be reduced strength of the connection point due to a material change, and the quality team will monitor this issue for trending purposes.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: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50692207
• Report Number: 1417592-2026-34813
• Device Sequence Number: 20306171
• Product Code: BYG
• UDI-Device Identifier: 10197344009626
• UDI-Public: 10197344009626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/04/2026

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: (10)25FOA648
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2025
• 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: 11/21/2025
• Initial Report FDA Received Date: 09/09/2026
• 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: Unknown