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

Catalog Number	HUDRHO41U
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	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tube that connects to the mask is coming disconnected during cases and transport.".
Additional Manufacturer Narrative
The customer stated that the tube that connects to the mask is coming disconnected during cases and transport; the issue did not occur during use and no injury occurred.Medline quality received 2 samples, visually inspected the samples, observed that the samples did not arrive in the original packaging, and observed all samples to be in good condition with no tears in the mask or tubing; the tubing of each sample was observed to be coming off the mask component.The cause of the tubing disconnecting from the mask could not be confirmed.Based on the manufacture response, the root cause is not related to a manufacturing problem, and an investigation was carried out on the received sample confirming that the results were accepted according to the established procedures.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: rahul kota ; three lake drive; northfield, IL 60093--275
• MDR Report Key: 50933362
• Report Number: 1417592-2026-53207
• Device Sequence Number: 10759777
• Product Code: BYG
• UDI-Device Identifier: 10197344010646
• UDI-Public: 10197344010646
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/22/2026

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: 25DOA382
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2025
• 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: 08/21/2025
• Initial Report FDA Received Date: 09/29/2026
• 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