MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; HOLDER,TRACH TUBE,ADULT, TWO PIECE

Catalog Number	DYN540H
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	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the comforting piece is separating from the foam trach tie.
Additional Manufacturer Narrative
The complaint stated the comforting piece is separating from the foam trach tie.Samples were received for investigation; medline quality evaluated the foam neckbands and attempted to replicate the issue, and observed that the white material can be pulled away from the foam neckbands with reasonable external force / effort.Medline could confirm the issue of the comfort material separating and could confirm the product failed to meet specifications as the white comfort material should not separate from the blue foam component.According to the vendor, the cause is considered to be an issue relating to the manufacturing process of the product, 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: HOLDER,TRACH TUBE,ADULT, TWO PIECE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50766460
• Report Number: 1417592-2026-40267
• Device Sequence Number: 9667917
• Product Code: CBH
• UDI-Device Identifier: 10197344103607
• UDI-Public: 10197344103607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/14/2026

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: DYN540H
• Device Lot Number: TTHD-163Y
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2025
• 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: 04/08/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (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