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

Model Number	9002136
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
We are reporting 8 events that happened in the 5 months period, where the neulasta on-pro (pegfilgrastim) device either failed to deploy, fell off, and/or leaked.Each device was reported to and sent back to the company.Each device was assessed by the company.Devices were replaced by the manufacturer.These events resulted in delayed treatment and inconvenience for the patients.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 13042681
• Report Number: 13042681
• Device Sequence Number: 19822798
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 12/16/2021

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
• Device Lot Number: A41042-0006145
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 12/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2021
• 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: Unknown
• Date Report Sent to FDA: 12/16/2021