MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STOPCOCK,3-WAY,45,PSI,LOW,OFF,ROT,COLAR

Catalog Number	DYNJSC301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have 2 lot# 3 way low pressure stopcock with rotating male collar ref#(b)(6), sin#2157161 that are defective and leak out of the valve.".
Additional Manufacturer Narrative
The customer reported the 3 way low pressure stopcock with rotating male collar are defective and leak out of the valve.Thirty-nine unused samples were returned for evaluation; visual evaluation of the returned sample did not reveal any defects, and a 10 ml syringe was filled with water.Eight of the thirty-nine returned samples leaked upon aspiration, the complaint was able to be duplicated with the available samples, and the reported defect is confirmed.Root cause can be attributed to vendor design deviation, and the quality team will monitor this issue for trending purposes.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,3-WAY,45,PSI,LOW,OFF,ROT,COLAR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884102
• Report Number: 1417592-2026-49950
• Device Sequence Number: 13218155
• Product Code: DTL
• UDI-Device Identifier: 40884389734569
• UDI-Public: 40884389734569
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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: 22IBU132
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2024
• 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: 07/16/2024
• Initial Report FDA Received Date: 09/24/2026
• 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