MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE

Catalog Number	URO170816TSQ
Medical Device Problem Codes	Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that temperature probe disengaged from catheter inner lumen and was leaking.
Additional Manufacturer Narrative
The reported failure was that the temperature probe disengaged from the catheter inner lumen and was leaking; no patient harm nor medical intervention reported.Medline performed a standard investigation, but no sample was available; the vendor has been notified of this issue, and urology qa is conducting internal testing and working with vendor to reduce risk of detachment/displacement.The complaint was unable to confirm at this time, and the cause was sample required to determine cause.Based on findings, appropriate corrective actions will be taken, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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 CAUTI TEMP SENS MF 16FR 10ML SAFE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joachim kamanda ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50820010
• Report Number: 1417592-2026-44843
• Device Sequence Number: 18673902
• Product Code: OHR
• UDI-Device Identifier: 40193489723428
• UDI-Public: 40193489723428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/17/2026

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: URO170816TSQ
• Was Device Available for Evaluation?: Yes
• 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: 11/30/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (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