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

Catalog Number	DYND40589
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in the tracheostomy clean and care kit; dynd40589, the bristles in the tracheostomy brush are falling off.".
Additional Manufacturer Narrative
The account reported finding "bristles falling off" and the customer reported that the bristles in the tracheostomy brush are falling off.Medline quality received one case of (b)(6); the sample arrived in its original packaging, and a portion of the received samples were sent to the manufacturer for investigation.Based on the manufacturer's investigation, the bristles were not falling off at the connection to the handle; pieces of the bristle broke off during a phase of the manufacturing process where the bristles are attached to the handle.The root cause was determined to be the manufacturing process, and the manufacturer has installed corrective actions to better detect these occurrences during the manufacturing/packaging process.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: TRAY,TRACH,SALINE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50916073
• Report Number: 1417592-2026-52098
• Device Sequence Number: 17642010
• Product Code: LRO
• UDI-Device Identifier: 40080196032823
• UDI-Public: 40080196032823
• 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): 09/25/2026

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: DYND40589
• Device Lot Number: 2024031390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2024
• 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: 09/24/2024
• 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