MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR 18FR10ML 100%SILI UMST TR

Catalog Number	URO170818S
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, it was noticed that the foley catheter was not draining properly and leaking around the cath insertion site.Catheter was removed and then patient was straight cathed with large amount of urine collected.Facility reports no serious injury.Individual is doing "fine." no additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Lot number 25abu211 has a manufcturing date of 2/5/2025 and an expiration date of 5/31/2026.Lot number 25cbd896 has a manufacturing date of 3/10/2025 and an expiration date of 3/31/2026.Lot number 25cbr656 has a manufacturing date of 3/28/2025 and an expiration date of 3/31/2026.
Event or Problem Description
According to the facility, on (b)(6) 2025, it was noticed that the foley catheter was not draining properly and leaking around the catheter insertion site.The catheter was removed and the patient was straight catheterized with large amounts of urine collected.Facility reports no serious injury.Individual is doing "fine".

• Common Device Name: 1LYR 18FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23078659
• Report Number: 1417592-2025-00488
• Device Sequence Number: 18576387
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: URO170818S
• Device Lot Number: 25ABU211, 25CBD896, 25CBR656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown