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

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called following day, about an hour before the dose was to be injected, reporting that device beeped and started flashing red light.Patient was instructed to call md office next day to arrange for neulasta sq injection.

• Brand Name: AMGEN NEULASTA ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 16395890
• Report Number: 16395890
• Device Sequence Number: 5353187
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2023
• Report Date (Section F): 02/13/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2023
• 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: 02/13/2023