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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was discharged with neulasta on-body on [date redacted] per usual procedure, device applied to abdomen.Patient called clinic back on [date redacted] - the next day, at approximately 0900 stating that the device was "hanging off." patient suspected she knocked the device by accident when closing a fridge door.Nurse coordinator arranged for patient to come back to the clinic for neulasta injection.The patient was discharged.Nurses confirmed that the device did not deliver a dose.

• 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: 22838165
• Report Number: 22838165
• Device Sequence Number: 9365939
• 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): 08/04/2025
• Report Date (Section F): 08/04/2025

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: 08/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2025
• 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: 61 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/04/2025