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

Catalog Number	URO175816
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A foley catheter balloon ruptured during a procedure.The foley catheter was discontinued at the end of the procedure.
Additional Manufacturer Narrative
A foley catheter balloon ruptured during a procedure.The foley catheter was discontinued at the end of the procedure.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.

• Common Device Name: 1LYR TRY 16FR 10ML 100% SILI UM SNAP
• 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: 22470443
• Report Number: 1417592-2025-00330
• Device Sequence Number: 7904863
• Product Code: OHR
• UDI-Device Identifier: 10193489987461
• UDI-Public: 10193489987461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: URO175816
• Device Lot Number: 25DBA626
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 66 KG