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

Model Number	9002136
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The on-body device did not adhere to the patient and did not infuse.Patient noted the device blinking red.The catheter did not perforate the skin and was lying up against the skin.Clear plastic aspect around the catheter was dislodged.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 22059871
• Report Number: 22059871
• Device Sequence Number: 7865765
• 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): 05/19/2025
• Report Date (Section F): 05/19/2025

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
• Date Report to Manufacturer: 05/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• 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 Age: 62 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/19/2025