MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYR TRY 16FR 10ML 100% SIL UM SNAP

Catalog Number	URO175816C
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Chemical Exposure (2570)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "catheter disconnected from urine meter during chemotherapy procedure, leading to leakage of urine + chemotherapy drug.".
Additional Manufacturer Narrative
The customer reported that the catheter disconnected from the drain bag tubing during intravesical chemotherapy, and the patient and nurse were exposed to the chemotherapy drug due to the disconnection.Medline quality did not receive a sample nor photographs of the reported product; a review of the device history record for the reported item found no similar issues reported, and a post-market retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of catheter disconnection with respect to uro175816c.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 monthly 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 TRY 16FR 10ML 100% SIL UM SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50674490
• Report Number: 1417592-2026-34127
• Device Sequence Number: 10423419
• Product Code: OHR
• UDI-Device Identifier: 10193489988727
• UDI-Public: 10193489988727
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/04/2026

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: URO175816C
• Device Lot Number: 24KBO453
• Was Device Available for Evaluation?: No
• 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: 02/06/2025
• 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