MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY FOL TEMP UM 16FR 10ML MF

Catalog Number	DYND150816TS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer contact, on (b)(6) 2026, a foley catheter was inserted, and after the syringe was disconnected, "fluid was noticed at the urethral opening coming out around the catheter and upon retraction of the catheter, it completely came out." the foley balloon was then tested after removal and was shown to be leaking.
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2026, a foley catheter was inserted, and after the syringe was disconnected, "fluid was noticed at the urethral opening coming out around the catheter and upon retraction of the catheter, it completely came out." the foley balloon was then tested after removal and was shown to be leaking.Facility reported another catheter had to be placed, no further medical interventions or follow-up care reported.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.

• Brand Name: MEDLINE
• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 24252973
• Report Number: 1417592-2026-00084
• Device Sequence Number: 9970979
• Product Code: OHR
• UDI-Device Identifier: 10195327149871
• UDI-Public: 10195327149871
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: DYND150816TS
• Device Lot Number: 25GBE843
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White