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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "foley catheter did not seal at hose/bag and the securment device did not adhere correctly".
Additional Manufacturer Narrative
The complaint reported that the foley catheter did not seal at hose/bag and the securement device did not adhere correctly; customer is at the er.Medline quality did not receive a sample nor photographs of the reported product, and review of the device history record found no similar reported issues; a post-market retrospective review of the past 6 months preceding the reported issue revealed 0 additional complaints of catheter to hose sealing issues and no known trends.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 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 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50759114
• Report Number: 1417592-2026-39755
• Device Sequence Number: 21220161
• Product Code: OHR
• UDI-Device Identifier: 40193489988728
• UDI-Public: 40193489988728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2026

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: 24ABI651
• 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: 03/25/2024
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown