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

Catalog Number	URO175816
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "so far one person has complained that the bag is leaking urine.That she has experienced this happening three times.".
Additional Manufacturer Narrative
According to the customer, all 3 cases had the foley placed at the beginning and at the end of surgery urine was found on the floor under the urine bag; bags were inspected to make sure the closure device was in place, and all 3 were found to be in the locked position.Medline quality did not receive a sample nor photographs of the reported product, and a post-market retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of drain bag leakage with respect to (b)(4).The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.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% SILI UM SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855304
• Report Number: 1417592-2026-47686
• Device Sequence Number: 9923514
• Product Code: OHR
• UDI-Device Identifier: 40193489987462
• UDI-Public: 40193489987462
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: URO175816
• Device Lot Number: 23LBU186
• 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: 05/07/2024
• Initial Report FDA Received Date: 09/22/2026
• 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