MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 16FR 10ML TEMP SENS SIL UM MF

Catalog Number	URO170816TS
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	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the sample port (foley flushable port) came apart when rn went to flush the catheter.".
Additional Manufacturer Narrative
The customer reported that on (b)(6) 2026, the sample port came apart when rn went to flush the catheter; rn disconnected the urine meter tubing from catheter and replaced without issue, and the individual was "fine." medline quality received the reported product in unpackaged, used condition, and an assessment of the returned sample was conducted based on established inspection criteria.Visual assessment revealed that the sample port valve was seated within the housing, and the valve was able to be removed from the housing with little resistance, verifying the reported issue.The reported issue was confirmed with the returned sample and was attributed to an inadequate application of solvent adhesive during manual sample port assembly.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: 16FR 10ML TEMP SENS SIL UM MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50674411
• Report Number: 1417592-2026-34119
• Device Sequence Number: 21441528
• Product Code: OHR
• UDI-Device Identifier: 10889942127955
• UDI-Public: 10889942127955
• 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): 09/03/2026

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: URO170816TS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2026
• 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: 02/23/2026
• Initial Report FDA Received Date: 09/08/2026
• 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