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

Catalog Number	DYND150816TS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, there have been multiple incidents of the catheters "not draining the bladder" and the customer believes an "obstruction may have occurred at the tip of the catheter".The customer reported "urine retention" was confirmed with a "bladder scan", and a new catheter was inserted due to the reported issue.The customer reported "the patient bladders were drained following catheter replacement" and "there was no indication of patient harm or negative outcome after replacement".The customer did not report any serious injury related to the reported event.No additional information was provided.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
According to the customer, there have been multiple incidents of the catheters "not draining the bladder" and the customer believes an "obstruction may have occurred at the tip of the catheter".

• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21772876
• Report Number: 1417592-2025-00161
• Device Sequence Number: 8199817
• Product Code: OHR
• UDI-Device Identifier: 10195327149871
• UDI-Public: 10195327149871
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/04/2025

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 Expiration Date: 11/30/2025
• Device Catalogue Number: DYND150816TS
• Device Lot Number: 25ABA232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/04/2025
• 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: Unknown