MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STOPCOCK 4-WAY HIGH FLW SWIVEL

Catalog Number	DYNJSC4HPFF
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we experienced that the vast majority of this product would leak, the valve, flow swivel, was not effective in stopping fluid from flowing.".
Additional Manufacturer Narrative
The account reported finding stopcock leak, and the customer reported that the product would leak and the valve, flow swivel, was not effective in stopping fluid from flowing.No sample or photo was received for the investigation; finished good production records were reviewed, the reported pack and lot did not match, and finished good pack build review identified no issues that would have contributed to the reported concern.Without a sample or photo to identify the stopcock, the investigation was limited and not able to confirm the reported defect.The cause was documented as sample required to determine cause, and the division will monitor for trending.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: STOPCOCK 4-WAY HIGH FLW SWIVEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854576
• Report Number: 1417592-2026-47537
• Device Sequence Number: 21316164
• Product Code: OEZ
• UDI-Device Identifier: 10889942926985
• UDI-Public: 10889942926985
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/22/2026

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: DYNJSC4HPFF
• Device Lot Number: 25CBI579
• 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: 05/02/2025
• Initial Report FDA Received Date: 09/22/2026
• 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 Sex: Unknown