MAUDE Adverse Event Report: AMGEN INC. ONPRO KIT 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	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device failed to deliver the dose of pegfilgrastim.No injury or potential injury had occurred, patient was instructed to come back to clinic to receive neulasta sq injection instead.

• Brand Name: ONPRO KIT ON-BODY INJECTOR FOR NEULASTA
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 15040166
• Report Number: 15040166
• Device Sequence Number: 6983115
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2022
• Report Date (Section F): 07/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2022
• 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: 07/08/2022