MAUDE Adverse Event Report: Medline Industries, LP Medline; TRAY FCMS URNMTR SIL 14FR 10ML

Catalog Number	URO170814
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a 14 french foley catheter placed.Staff attempted to empty the foley bag and noted the green drainage tube would not drain, and the bag itself appeared to be vacuum sealed together.
Additional Manufacturer Narrative
It was reported that the patient had a 14 french foley catheter placed.Staff attempted to empty the foley bag and noted the green drainage tube would not drain, and the bag itself appeared to be vacuum sealed together.When attempting to pull apart the seal, the bag began to leak slightly.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.

• Brand Name: Medline
• Common Device Name: TRAY FCMS URNMTR SIL 14FR 10ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haley barclay ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50888794
• Report Number: 1417592-2026-50422
• Device Sequence Number: 9791533
• Product Code: OHR
• UDI-Device Identifier: 10888277866645
• UDI-Public: 10888277866645
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: URO170814
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Race: Asian