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

Catalog Number	HUD1007
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "loose oxygen tubing on mask.The tubing comes off the nipple port of the mask easily.".
Additional Manufacturer Narrative
The account reported finding "loose oxygen tubing on mask," and the facility stated that "the oxygen tubing connection at the mask is very loose and easily disconnects with minimal force" and "this results in a hypoxic environment within the mask." a photo was received for the investigation; photographs depicted a product label and one oxygen mask in its original packaging along with the sample insert, the photos were visually inspected, the dhr was reviewed, and materials from the production line were inspected according to rci hudson specifications.Due to not receiving the actual sample used, the root cause could not be determined, and the complaint cannot be confirmed.The dhr showed no issues or discrepancies, the materials were found within specifications, and no confirmed medical intervention or serious injury was 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: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805008
• Report Number: 1417592-2026-43793
• Device Sequence Number: 8597421
• Product Code: BYG
• UDI-Device Identifier: 10197344011605
• UDI-Public: 10197344011605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/16/2026

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: 25FOA878
• 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: 03/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown