MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TTL1LYR 16FR10ML C LTX UM Q

Catalog Number	URO170216CQ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rn removed syringe and the entire injection port dislodged and allowed chemotherapy/urine to pour out of the opening resulting in a chemotherapy spill.This is the second failure in a weeks time.".
Additional Manufacturer Narrative
The customer reported sample port detachment with respect to the one layer latex foley catheter tray, 16fr, 10 ml, and stated that the sampling port was used for the instillation of chemotherapy drugs into the bladder.Medline quality received 3 cs of the reported product in packaged, unused condition; visual assessment of the provided product revealed no abnormalities or nonconformances, and functional testing was conducted by connecting a luer lock syringe and twisting.Out of 20 ea tested, 4 ea¿s sample ports detached, thus verifying the reported issue, and the likely root cause is an inadequate application of solvent adhesive during sample port assembly.The reported issue has been addressed with corrective actions to improve the sample port assembly process, and no additional actions are necessary at this time.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: TTL1LYR 16FR10ML C LTX UM Q
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; three lakes drive, IL 60093--275
• MDR Report Key: 50754839
• Report Number: 1417592-2026-39301
• Device Sequence Number: 13126652
• Product Code: OHR
• UDI-Device Identifier: 10193489894240
• UDI-Public: 10193489894240
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/09/2026

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: URO170216CQ
• Device Lot Number: 25GBU379
• 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: 10/23/2025
• 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