MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HME, TRACH

Catalog Number	DYNJAAHME30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Cough (4457)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the trachs are falling apart and the filter fall out within an hour of putting it on.".
Additional Manufacturer Narrative
The customer reported that filters would "explel out with coughing & sometimes while just breathing" and have had to change very frequently, nearly every hour to 2 hours; per the customer there was "no choking or falling into airway.No medical emergency." medline quality received and inspected two photos which appeared in used condition and the left side of the filter when looking at the photo was no longer in place.As a result, one side of the filter has come out was confirmed, however, medline was unable to determine a root cause without a physical sample.A retrospective query on the item number for the past six months found no similar complaint(s), the manufacturing site was notified of the issue, and the division will monitor the complaint during quarterly trending.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: HME, TRACH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50694876
• Report Number: 1417592-2026-35058
• Device Sequence Number: 9685138
• Product Code: BYD
• UDI-Device Identifier: 40888277333421
• UDI-Public: 40888277333421
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/04/2026

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: DYNJAAHME30
• Device Lot Number: 2233501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/26/2023
• 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: 03/30/2023
• Initial Report FDA Received Date: 09/09/2026
• 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: Male
• Patient Weight: 110 LB