MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 3-WY LOW PRSSRE SWIVEL LCK OFF

Catalog Number	DYNJSC301
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "some of our stopcocks from medline have been failing and have a leak" and "they seem to have a leak in the hole on the backside of the device, on the opposite side of the knob.".
Additional Manufacturer Narrative
The customer reported stopcocks failing with a leak, and when pulling or pushing, air or water came out of the hole on the back of the device; the customer also reported several patients were misdiagnosed with air around their lungs due to the faulty stopcock.Finished good production records and finished good pack build were reviewed, and samples were received for investigation; thirty-two pieces were tested by flushing the device with a syringe that contained water.It was confirmed that two of the thirty-two pieces had water leak from the handle of the stopcock.The root cause can be attributed to vendor design deviation, and there has been no change to the reportability decision associated with this complaint.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: 3-WY LOW PRSSRE SWIVEL LCK OFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900419
• Report Number: 1417592-2026-51273
• Device Sequence Number: 6001753
• Product Code: DTL
• UDI-Device Identifier: 40884389734569
• UDI-Public: 40884389734569
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/24/2026

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: DYNJSC301
• Device Lot Number: 24ABC638
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2024
• 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: 03/22/2024
• Initial Report FDA Received Date: 09/25/2026
• 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