MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TR1LYR 6FR 3ML100%SIL TMP PEDS

Catalog Number	DYND160806T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "over this past year, we have had 4 6 fr temp sensing foleys malfunction.The temperature sensing metal looking part stopping working and then it is found that the foley itself is punctured by it, found by urine leaking.".
Additional Manufacturer Narrative
The customer reported that over the past year, 4 6 fr temp sensing foleys malfunctioned, with the temperature sensing metal looking part stopping working and the foley itself punctured by it, found by urine leaking; no injury or patient/clinician harm was reported.Medline quality did not receive a sample nor photographs of the reported product of this incident, and a post-market retrospective review of the past 24 months preceding the reported issue revealed 4 total complaints of temperature reading failures with respect to this product at this time.The issue is unconfirmed, as no samples nor photographs were made available to review, and a root cause cannot be identified at this time.Medline quality will continue to monitor for the issue through monthly complaint meetings and quarterly trending analysis.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: TR1LYR 6FR 3ML100%SIL TMP PEDS
• 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: 50838252
• Report Number: 1417592-2026-45879
• Device Sequence Number: 21398248
• Product Code: OHR
• UDI-Device Identifier: 10889942148226
• UDI-Public: 10889942148226
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: DYND160806T
• 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: 01/12/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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