MAUDE Adverse Event Report: MEDLINE INDUSTIRES, LP- NAMIC NAMIC; MMII,MP,3V,200S,RH,OFF,OEM

Catalog Number	80038301
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, after first shot of right coronary artery, the syringe connection became loose, and contrast ran out from the connection.Syringe was unstable to stay on manifold, and the syringe was changed out.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 (b)(4) 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
According to the facility, after first shot of right coronary artery, the syringe connection became loose, and contrast ran out from the connection.Syringe was unstable to stay on manifold, and the syringe was changed out.
Additional Manufacturer Narrative
Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).Updated h7: if remedial action initiated, check type.Updated h9: if action reported to fda under 21 usc 360i(g), list correction/removal reporting number.

• Brand Name: NAMIC
• Common Device Name: MMII,MP,3V,200S,RH,OFF,OEM
• Manufacturer (Section D): MEDLINE INDUSTIRES, LP- NAMIC; 10 glen falls technical park; technical park drive; glen falls NY 12801 3864
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24562852
• Report Number: 3015910259-2026-00082
• Device Sequence Number: 8932914
• Product Code: DTL
• UDI-Device Identifier: 10193489066500
• UDI-Public: 10193489066500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K782095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 80038301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-025
• Patient Sequence Number: 1
• Patient Sex: Unknown