MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 14FR 10ML TEMP SENS SIL UM MF

Catalog Number	UROT1100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the foley bag was leaking urine.There was a small hole in the lower left corner of the foley bag.".
Additional Manufacturer Narrative
The customer reported a leaking drainage bag and stated that urine was on the floor and the foley bag was leaking urine with a small hole in the lower left corner of the foley bag.Medline quality received 1 ea of the reported product in unpackaged, used condition; visual assessment revealed no defects nor abnormalities, and functional testing was conducted by filling the drainage bag with 800 ml of liquid and conducting a hang test to observe for leaks.No leaks were observed and could not be found at the reported location; the reported issue of drain bag leakage could not be verified based on visual or functional inspection of the received sample.The cause was not confirmed with received sample, and 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: 14FR 10ML TEMP SENS SIL UM MF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804735
• Report Number: 1417592-2026-43742
• Device Sequence Number: 8653555
• Product Code: OHR
• UDI-Device Identifier: 10193489491081
• UDI-Public: 10193489491081
• 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: UROT1100
• Device Lot Number: 0332208A060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2025
• 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: 03/11/2025
• Initial Report FDA Received Date: 09/17/2026
• 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