MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1LYRTR 16FR10ML 100%SILI SNAP

Catalog Number	URO175716
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the first ballon did not inflate the second ballon fell apart.".
Additional Manufacturer Narrative
The customer reported a foley balloon tear and a hole in the balloon, and the complaint stated the first balloon did not inflate and the second balloon fell apart.Medline quality did not receive a sample nor photographs of the reported product; a review of the inspection record for the reported item found no similar issues reported, and the vendor's review of records, manufacturing process, and testing of retained samples found no defects or evidence of a nonconformance in their production.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 are currently no known trends for these product lots, and there has been no change to the reportability decision associated with this complaint.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: 1LYRTR 16FR10ML 100%SILI SNAP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754850
• Report Number: 1417592-2026-39303
• Device Sequence Number: 9631519
• Product Code: OHR
• UDI-Device Identifier: 10193489987423
• UDI-Public: 10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: URO175716
• Device Lot Number: 25KBH464
• 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: 01/27/2026
• 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