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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called while travelling home within 60 minutes of leaving the infusion center and reported red light flashing and continuous beeping tone.No injury was reported.Patient instructed to come back for device replacement.

• Brand Name: NEULASTA ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 16223472
• Report Number: 16223472
• Device Sequence Number: 11906950
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/09/2023
• Report Date (Section F): 01/09/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/09/2023