MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; O2 MASK,REBREATH,ADULT,7' TUB SC

Catalog Number	HUD1007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "oxygen tubing falling off the connection point at the mask.".
Additional Manufacturer Narrative
The customer reported oxygen tubing falling off the connection point at the mask; treatment was able to be provided and there were no instances of hypoxia or breathing decline due to the product issue, and no patient harm.Medline quality received 1 sample, visually inspected the sample, and observed that the mask was in good condition with no damage noted on the mask or tubing; the tubing that comes with the mask component was observed to be coming off easily when placed on the mask.Manufacturing evaluation observed that the piece and the tube had disconnected, and a functional test was performed with the 5 lb weight test to ensure the correct connection between the grommet and the female connector; the results were accepted according to the established procedure.Based on the result of functional inspection, customer complaint cannot be confirmed; the equipment is within specification and functional, and no discrepancies were found that could be related with the condition reported.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,REBREATH,ADULT,7' TUB SC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668606
• Report Number: 1417592-2026-33629
• Device Sequence Number: 10174588
• Product Code: BYG
• UDI-Device Identifier: 10197344011605
• UDI-Public: 10197344011605
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/03/2026

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: HUD1007
• Device Lot Number: 25HOA840
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2026
• 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: 11/10/2025
• Initial Report FDA Received Date: 09/08/2026
• 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