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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
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 customer reported issues with the temperature probe disengaged from catheter inner lumen and leaking; patient was not harmed and no intervention was needed.Medline quality received 1 ea of the reported product in unpackaged, used condition, and visual assessment revealed that the temperature probe was dislodged from its position in the foley catheter and could move freely in and out of the catheter.The reported issue was verified by visual assessment of the provided sample, thus confirming the reported complaint.Based on the provided sample and the description of the issue, the likely root cause is a manufacturing defect resulting in reduced temperature probe connectivity with the foley catheter; due to the low reported occurrence rate of this issue, no further corrective action is necessary at this time and the vendor will be notified of this complaint.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: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691947
• Report Number: 1417592-2026-34777
• Device Sequence Number: 5975621
• Product Code: OHR
• UDI-Device Identifier: 40193489723428
• UDI-Public: 40193489723428
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/04/2026

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
• Device Lot Number: 592220310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/12/2023
• 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: 01/06/2023
• Initial Report FDA Received Date: 09/09/2026
• 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