MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SCOUT REFLECTOR AND DELIVERY SYSTEM

Catalog Number	SSR75-01/N
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges the packaging was compromised and they did not feel comfortable using the device.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.If the device is returned at a later date, the complaint will be reopened and a complete evaluation will be performed.

• Brand Name: SCOUT REFLECTOR AND DELIVERY SYSTEM
• Common Device Name: REFLECTOR AND DELIVERY SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22286383
• Report Number: 2032338-2025-00001
• Device Sequence Number: 8930109
• Product Code: NEU
• UDI-Device Identifier: 00884450719510
• UDI-Public: 00884450719510
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: SSR75-01/N
• Device Lot Number: H3020625
• 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: 06/16/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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