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

Catalog Number	URO170816TS
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	08/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "detached sample port.".
Additional Manufacturer Narrative
This is a combination product the customer/reporter described the issue as "detached sample port" for 1 ea of (b)(6), and reported that no patient was harmed during this incident/observation.Medline quality received 1 ea of the reported product, and visual assessment of the provided product revealed the reported defect.The reported issue of detached sample port was verified by visual assessment of the provided sample; the sample port was completely detached from the sample port housing of foley catheter, thus confirming the complaint.The root cause has been attributed to a welding error during the product assembly process, and medline quality will continue to monitor for the issue through weekly complaint meetings and monthly 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: 16FR 10ML TEMP SENS SIL UM MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946990
• Report Number: 1417592-2026-54368
• Device Sequence Number: 13136409
• Product Code: OHR
• UDI-Device Identifier: 40889942127956
• UDI-Public: 40889942127956
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 09/29/2026

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: 09/13/2023
• 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: 08/31/2023
• Initial Report FDA Received Date: 09/30/2026
• 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