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	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "the tubing is loose and comes off the mask easily.".
Additional Manufacturer Narrative
The reported issue was that the tubing is loose and comes off the mask easily.No sample or photo was received for the investigation; the complaint was provided to the manufacturing site for further evaluation and a response was received, and the quality team reviewed trend reports for trending purposes.The reported problem could not be evaluated by sample or photo, but the item/lot was confirmed to be associated with a recall.The potential root cause of the reported issue was determined to be reduced strength of the connection point due to a material change, and there has been no change to the reportability decision associated with this complaint.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: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50566513
• Report Number: 1417592-2026-30543
• Device Sequence Number: 21309460
• Product Code: BYG
• UDI-Device Identifier: 10197344010646
• UDI-Public: 10197344010646
• 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): 09/01/2026

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: (10)25FOA288
• 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: 10/22/2025
• Initial Report FDA Received Date: 09/02/2026
• 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