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	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stopcocks are leaking.
Additional Manufacturer Narrative
The account reported finding stopcocks are leaking.No sample or photo was received for investigation; finished good production records were reviewed and there were no line down situations, deviations, run-withouts, or non-conformance reports that might have had an impact on this issue, and the finished good pack build was reviewed.Because no sample or photo was received, the reported issue could not be evaluated on a returned sample; medline noted that the item is received from the vendor and is not altered during the kit assembly process.The component manufacturing facility identified that the leaking is caused by a mold deviation which leads to uneven wall thickness of the item.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: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898844
• Report Number: 1417592-2026-51060
• Device Sequence Number: 14952617
• Product Code: DTL
• UDI-Device Identifier: 40884389734569
• UDI-Public: 40884389734569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: (10)23CBL808
• Was Device Available for Evaluation?: Yes
• 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: 12/04/2023
• Initial Report FDA Received Date: 09/25/2026
• 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