MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR TRY 16FR 10ML 100% SILTMP SNP

Catalog Number	URO175816T
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025 the foley balloon ruptured "hours after insertion".The customer reported a new foley catheter was inserted due to the reported issue.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the foley balloon ruptured "hours after insertion".The customer reported a new foley catheter was inserted due to the reported issue.The customer did not report any serious injury related to the reported event.No additional information is available at this time.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.
Additional Manufacturer Narrative
Update to d4: lot number.Update to h6: type of investigation.Update to h6: investigation findings.

• Common Device Name: 1LYR TRY 16FR 10ML 100% SILTMP SNP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21904086
• Report Number: 1417592-2025-00197
• Device Sequence Number: 18325186
• Product Code: OHR
• UDI-Device Identifier: 10193489988505
• UDI-Public: 10193489988505
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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
• Device Catalogue Number: URO175816T
• Device Lot Number: 25ABQ594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 Sex: Female
• Patient Weight: 43 KG