MAUDE Adverse Event Report: AMGEN USA, INC. ONPRO KIT; INTRODUCER, SYRINGE NEEDLE

Model Number	9002136
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called hospital the day after placement reporting a red light flashing, chamber read full.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 21312704
• Report Number: 21312704
• Device Sequence Number: 8811896
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/22/2025
• Report Date (Section F): 01/22/2025

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
• Device Model Number: 9002136
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 01/22/2025