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

Catalog Number	URO175716
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the md noticed a difference as he inflated the balloon on the catheter.He pulled on the catheter and the foley came out.The balloon was noted to have ruptured.A new foley was inserted.There were no reports of serious injury.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.
Event or Problem Description
It was reported that the md noticed a difference as he inflated the balloon on the catheter.He pulled on the catheter and the foley came out.The balloon was noted to have ruptured.A new foley was inserted.There were no reports of serious injury.
Additional Manufacturer Narrative
Update to h6.After further investigation, it was determined that the evaluation involved testing of the actual/suspected device, an analysis of production records, and a trend analysis.The investigation identified a material problem, as visual assessment of the provided product revealed a longitudinal tear on the catheter balloon, and a leakage/seal problem was confirmed.Functional testing was performed by attempting to inflate the balloon with 10 ml of water, and it was observed that the balloon was no longer able to retain fluid, thereby verifying the reported issue.However, despite confirmation of the malfunction, the cause remains unestablished.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: 1LYRTR 16FR10ML 100%SILI 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: 24037132
• Report Number: 1417592-2026-00031
• Device Sequence Number: 18711226
• Product Code: OHR
• UDI-Device Identifier: 10193489987423
• UDI-Public: 10193489987423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: URO175716
• Device Lot Number: 25FBL914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2026
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 69 KG