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

Catalog Number	DYND150816TS
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sample port detachment.".
Additional Manufacturer Narrative
Medline quality received a complaint regarding sample port detachment with respect to the dynd150816ts; the complaint stated "was the patient or clinician harmed during this incident/observation? not to our knowledge" and "was any medical intervention necessary? if applicable, was a new catheter inserted? no." an assessment of the returned sample was conducted based on established inspection criteria; visual assessment of the provided product revealed that the urine meters' sample port valves were able to be easily removed from the sample port housing, and a lack of solvent bonding was observed on the stems of the valves.The reported issue of sample port detachment was verified by visual assessment of the provided samples.The root cause is attributed to an inadequate application of solvent during the bonding process of the valve to the sample port housing, and this complaint will be closed as confirmed.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50757908
• Report Number: 1417592-2026-39719
• Device Sequence Number: 21249688
• Product Code: OHR
• UDI-Device Identifier: 10195327149871
• UDI-Public: 10195327149871
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYND150816TS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown