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

Lot Number	A406660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported neulasta on-body injector (obi) administered medication at 26 hours rather than 27 hours.Pt stated she did verify the fill indicator was at empty prior to removing obi.Pt did not save the device.Rn spoke to on-site pharmacist regarding medication delivery at 26 hours instead of 27 hours and she confirmed as long as administration was after 24 hours it was safe.
Event or Problem Description
Patient reported neulasta on-body injector (obi) administered medication at 26 hours rather than 27 hours.Pt stated she did verify the fill indicator was at empty prior to removing obi.Pt did not save the device.Rn spoke to on-site pharmacist regarding medication delivery at 26 hours instead of 27 hours and she confirmed as long as administration was after 24 hours it was safe.

• Brand Name: NEULASTA OBI
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 8517639
• Report Number: 8517639
• Device Sequence Number: 18777101
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019
• Report Date (Section F): 04/15/2019

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: No Information
• Device Lot Number: A406660
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/16/2019
• 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: 04/15/2019