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	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tubing is loose and is not staying connected to the mask.".
Additional Manufacturer Narrative
The customer reported finding the samples had loose tubing, and it was stated that tubing are loose and not staying connected to masks.Medline quality received 24 units and visually inspected the samples; 4 ea were received with tubing already disconnected, and 20 ea were still in their original packaging.The reported issue was confirmed for 4 ea, but the associated lots could not be confirmed, and the reported issue could not be accurately assessed for the unopened masks.The cause code was updated to dc:medline error/mfg.- mfg: material composition, and an additional cause code was added as defect confirmed: unknown responsible party - cannot determine cause w/received sample; in the event additional information becomes available this complaint will be reopened, updated, and investigated as necessary.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 lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916818
• Report Number: 1417592-2026-52211
• Device Sequence Number: 14801077
• 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): 09/18/2026

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: 25DOA653
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2025
• 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: 11/05/2025
• Initial Report FDA Received Date: 09/28/2026
• 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