MAUDE Adverse Event Report: NAMIC INDUSTRIES; MTS,3 VALVE,RH,OFF,MANIFOLD,KIT,CHRI

Catalog Number	600303114
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An issue with the control syringe was reported.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
Control syringe "would not work".
Additional Manufacturer Narrative
Updates made to: e1, e3.

• Common Device Name: MTS,3 VALVE,RH,OFF,MANIFOLD,KIT,CHRI
• Manufacturer (Section D): NAMIC INDUSTRIES; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 22328132
• Report Number: 3015910259-2025-00045
• Device Sequence Number: 15848612
• Product Code: OEZ
• UDI-Device Identifier: 10193489069907
• UDI-Public: 10193489069907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 600303114
• Device Lot Number: 25ABP137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 03/18/2026
• 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 Sex: Unknown