MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC; ST PAT 3 PORT ON KIT, W/ WASTE

Catalog Number	VASC1579
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025, during a left heart catheterization procedure, the contrast injection syringe detached from the manifold while attempting to inject contrast into the coronary arteries.The syringe was reattached but detached again during the case.The procedure was completed successfully using a new manifold kit.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
On (b)(6) 2025, during a left heart catheterization procedure, the contrast injection syringe detached from the manifold while attempting to inject contrast into the coronary arteries.The syringe was reattached but detached again during the case.The procedure was completed successfully using a new manifold kit.

• Common Device Name: ST PAT 3 PORT ON KIT, W/ WASTE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; glen falls NY 12801
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23396353
• Report Number: 3015910259-2025-00095
• Device Sequence Number: 10015297
• Product Code: OES
• UDI-Device Identifier: 10198459091216
• UDI-Public: 10198459091216
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1579
• Device Lot Number: 25CBU041
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 134 KG