MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC

Catalog Number	HUDRHO41U
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 7 ft oxygen tubing fell off of the connector of the mask on 5 different masks today.The connection feels very loose and it is very easy for the oxygen tubing to fall away and thereby not deliver any oxygen to the patient.
Additional Manufacturer Narrative
The account reported that the 7 ft oxygen tubing fell off of the connector of the mask on 5 different masks, the connection feels very loose, and it is very easy for the oxygen tubing to fall away and thereby not deliver any oxygen to the patient.No sample or photo received for the investigation; a medline canada complaint history review for the past 12 months was performed and review of the previous three trend reports was completed for trending purposes, with trends identified and actions taken for detaching components.The reported issue was confirmed based on the reported lot number and its association with a recall regarding reported issues of tubing disconnecting from oxygen masks; the manufacturing site has halted production using the resin identified as the root cause of the recall.Our 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: MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50483127
• Report Number: 1417592-2026-26434
• Device Sequence Number: 16033169
• Product Code: BYG
• UDI-Device Identifier: 10197344010646
• UDI-Public: 10197344010646
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/27/2026

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: HUDRHO41U
• Device Lot Number: 25GOA760
• Was Device Available for Evaluation?: No
• 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: 11/18/2025
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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