MAUDE Adverse Event Report: AMGEN USA, INC. ON-BODY INJECTOR FOR NEULASTA; INTRODUCER, SYRINGE NEEDLE

Model Number	9002136
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called following day stating red light flashing, chamber read full.

• Brand Name: ON-BODY INJECTOR FOR NEULASTA
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; one amgen center drive; thousand oaks CA 91320
• MDR Report Key: 19320283
• Report Number: 19320283
• Device Sequence Number: 20366399
• 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): 02/20/2024
• Report Date (Section F): 02/20/2024

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
• Device Model Number: 9002136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2024