MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO MAK-NV MINI ACCESS KIT NON-VASCULAR

Catalog Number	MAK-NV-017/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that when inserting the 0.018" guide wire through the 21g needle it became stuck.No medical intervention was deemed necessary and no foreign body introduction occurred.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.A search of the complaint database was performed and only one similar complaint was identified.Awareness training was completed with the relevant personnel as a precaution.

• Brand Name: MAK-NV MINI ACCESS KIT NON-VASCULAR
• Common Device Name: MINI ACCESS KIT NON-VASCULAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21746093
• Report Number: 3011642792-2025-00034
• Device Sequence Number: 9419259
• Product Code: GCB
• UDI-Device Identifier: 00884450088876
• UDI-Public: 00884450088876
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: MAK-NV-017/A
• Device Lot Number: I3011194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown