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

Model Number	9002136
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta on-pro ordered for patient to receive.Medication was removed from pyxis and sat out at room temperature for 30 minutes.Instructions were followed as directed by directions.During step 2 (the fill step), nursing injected the medication in the on-pro device.After this step, nursing is allowed three minutes to apply before cannula insertion.The cannula insertion started prior to the three minutes before nursing was able to apply the on-pro device.Neulasta on-pro was discarded appropriately and a new kit requested.Lot: 1134432a.Exp: 12/2023.

• Brand Name: NEULASTA ONPRO
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 12532035
• Report Number: 12532035
• Device Sequence Number: 13504245
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/20/2021
• Report Date (Section F): 09/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9002136
• Device Lot Number: 1134432A
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/20/2021