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

Catalog Number	URO175816
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); Genital Bleeding (4507)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the foley catheter was inserted without issue.When inflating foley balloon with kit provided flush the foley balloon not successfully inflated and "popped while inflating inside of patient".An additional foley catheter was attempted to be inserted.The patient complained of pain and some bleeding.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Balloon ruptured.

• Common Device Name: 1LYR TRY 16FR 10ML 100% SILI UM SNAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22472718
• Report Number: 1417592-2025-00331
• Device Sequence Number: 4106812
• Product Code: OHR
• UDI-Device Identifier: 10193489987461
• UDI-Public: 10193489987461
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• 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
• Device Catalogue Number: URO175816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male