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

Catalog Number	DYN542
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	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that trach tie seems to be coming apart from the foam.
Additional Manufacturer Narrative
The account reported the trach tie was coming apart; the customer indicated the issue did not occur during use and no injury occurred.A sample and photos were received for investigation; the photos received portray the trach tie comfort material separating from the foam, and visual/physical evaluation observed the white comfort material has been separated from the foam material.We could confirm the reported issue and confirm the products failed to meet specifications.According to the vendor, the cause is considered to be an issue related to a specific bonding step during the manufacturing process; our quality team will monitor this issue for trending purposes.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, NEONATE, TWO PIECE
• 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: 50856162
• Report Number: 1417592-2026-47840
• Device Sequence Number: 18530153
• Product Code: CBH
• UDI-Device Identifier: 10197344103621
• UDI-Public: 10197344103621
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/17/2026

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: DYN542
• Device Lot Number: TTHD-163Y
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2025
• 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: 11/18/2025
• Initial Report FDA Received Date: 09/22/2026
• 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