MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR 14FR 10ML 100%SILI UM TRAY

Catalog Number	DYND160814H
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "at point where the drain bag connects to the foley cath line there is a luer lock sampling port.This has been coming off and/or leaking urine.".
Additional Manufacturer Narrative
The customer reported that the luer lock sampling port at the point where the drain bag connects to the foley cath line has been coming off and/or leaking urine.Medline quality did not receive a sample nor photographs of the reported product, reviewed inspection records for the reported item, and performed post-market retrospective reviews, which found no similar issues reported and 0 additional complaints of sample port detachment.The issue is unconfirmed, as no samples nor photographs were made available to review.A root cause cannot be identified at this time, and medline quality will continue to monitor for the issue through bi-weekly complaint meetings and quarterly trending analysis.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: 1LYR 14FR 10ML 100%SILI UM TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668977
• Report Number: 1417592-2026-33677
• Device Sequence Number: 9512500
• Product Code: OHR
• UDI-Device Identifier: 10884389287408
• UDI-Public: 10884389287408
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/03/2026

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: DYND160814H
• Device Lot Number: 24KBL713
• Was Device Available for Evaluation?: Yes
• 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: 02/03/2025
• Initial Report FDA Received Date: 09/08/2026
• 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: Unknown