MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SC,3W,LP,FM,OFF,W,-,PG

Catalog Number	000000000070015003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a stopcock set up that is connected to the central lines (uvc or uac) that we are finding to be leaking.We had another incident over night which is now the third episode.".
Additional Manufacturer Narrative
The account reported finding stopcock leaking; the issue occurred during use and did an injury occur?: no.No sample or photo received for the investigation; the device history record was reviewed and there were no identified nonconformances that would have contributed to the reported defect, and no changes were noted in the finished good bom or pack build, in-process inspection prior to release, manufacturing instructions and design of the component that would have contributed to the reported defect.At this time, medline is unable to confirm the reported defect, stopcock leaking, as no physical sample or detailed photographic evidence was provided to support the investigation.Sample required to determine cause; based on the information available, no further action is required at this time, but medline will continue to monitor to determine if further action is needed in the future.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: SC,3W,LP,FM,OFF,W,-,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883442
• Report Number: 1417592-2026-49828
• Device Sequence Number: 18807553
• Product Code: DTL
• UDI-Device Identifier: 10193489064513
• UDI-Public: 10193489064513
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K2095
• 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: 000000000070015003
• Device Lot Number: 0000109868
• 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: 08/28/2025
• 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 Sex: Unknown