MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TTL1LYR 16FR10ML 100%SILI DB TRA

Catalog Number	URO170716
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "foley balloon pinhole leak" and "when reinflating the balloon, it was noted there was a tiny hole in the balloon and it was therefore leaking.".
Additional Manufacturer Narrative
The customer reported that on (b)(6) 2024 the foley catheter was noted to have "fallen out"; when inspecting the catheter and reinflating the balloon, a "tiny hole" in the balloon was noted, and the balloon was "leaking".Medline quality did not receive a sample nor photographs of the reported product, and a retrospective review of the past 6 months preceding the reported issue revealed no additional complaints of balloon failure with respect to uro170716; there are currently no known trends for this product lot.The issue is unconfirmed, as no samples nor photographs were made available to review.A root cause cannot be identified at this time; 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: TTL1LYR 16FR10ML 100%SILI DB TRA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50692938
• Report Number: 1417592-2026-34875
• Device Sequence Number: 20327497
• Product Code: OHR
• UDI-Device Identifier: 40888277866912
• UDI-Public: 40888277866912
• 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: URO170716
• Device Lot Number: 592211012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2024
• 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: 01/30/2024
• Initial Report FDA Received Date: 09/09/2026
• 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