MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH

Catalog Number	DYNCPTP14T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the product breaking, either cracking or breaking apart.".
Additional Manufacturer Narrative
The account reported finding the catheters breaking and cracking.Samples were received for investigation, and medline quality performed a visual/physical evaluation of the samples received; 2 ea had cracks on the blue t-component, but 1 ea did not appear to have any cracks or other damage.The reported issue was confirmed based on the samples received for one lot; regarding the additional reported lot, due to not receiving the actual samples used or photos of the issue/lot number, the reported issue could not be confirmed.The manufacturing records associated with the reported lots were not found to have any issues or otherwise that would relate to the reported issues, and a specific root cause could not be determined; the damage may have been caused by stress concentration resulting from excessive compressive forces on the area of concern.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: CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915291
• Report Number: 1417592-2026-51986
• Device Sequence Number: 14784921
• Product Code: OFR
• UDI-Device Identifier: 10888277703476
• UDI-Public: 10888277703476
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: DYNCPTP14T
• Device Lot Number: 06924050011
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2026
• 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: 12/22/2025
• 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