MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY, 1LYR 6FR 3ML100%SIL TEMP URN MTR

Catalog Number	URO170806T
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 after placement of the foley catheter, the patient was positioned for a procedure, and the "catheter fell out".The customer reported that there was "no tugging or pressure" applied during the positioning of the patient, and upon inspection of the catheter it was determined that the "balloon had ruptured".The customer reported that a new catheter was not placed, and the surgeon proceeded with the procedure.The customer did not report any serious injury related to the reported incident.No additional details are available related to the customer reported issue.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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2025 after placement of the foley catheter, the patient was positioned for a procedure, and the "catheter fell out".

• Common Device Name: TRAY, 1LYR 6FR 3ML100%SIL TEMP URN MTR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23523500
• Report Number: 1417592-2025-00619
• Device Sequence Number: 9785832
• Product Code: OHR
• UDI-Device Identifier: 10889942929160
• UDI-Public: 10889942929160
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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 Catalogue Number: URO170806T
• Device Lot Number: 25EBJ233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: 12 MO
• Patient Sex: Female
• Patient Race: White