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

Catalog Number	URO170216CQ
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	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "sample port dislodged from catheter while syringe attached, causing urine to pour from opening.".
Additional Manufacturer Narrative
According to the facility, "the rn used a foley coude catheter kit to place a foley catheter.Once placed, she attached a syringe to the sampling port which came out of the opening, allowing urine to flow out the opening"; facility stated, "the rn clamped the catheter, removed the defective bag and replaced it with a new foley bag".Medline quality received 1 ea of the reported product, which was received in unpackaged, used condition; visual assessment revealed that the sampling port valve was no longer fully seated within the housing, the valve could be removed with little resistance, and further examination noted the absence of solvent adhesive on the valve stem.The reported issue of sample port detachment was verified through assessment of the returned sample, and the root cause is an inadequate manual application of solvent adhesive during sample port assembly.No medical intervention, serious injury, or follow-up care has been reported, and there has been no change to the reportability decision associated with 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: TTL1LYR 16FR10ML C LTX UM Q
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL
• MDR Report Key: 50754818
• Report Number: 1417592-2026-39294
• Device Sequence Number: 9395866
• 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): 09/11/2026

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
• Date Returned to Manufacturer: 02/11/2026
• 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: 02/04/2026
• 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