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

Lot Number	1131930D
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Narrative from staff: patient had questionable injection of neulasta obi on cycle #1 of chemo.Patient called in and reported failure of device.Unclear if it was addressed by covering provider.Patient was subsequently admitted for sepsis and had subsequent cycles of chemotherapy dose reduced.Our team was informed of this event last week.

• Brand Name: NEULASTA OBI
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 12786274
• Report Number: 12786274
• Device Sequence Number: 17230712
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 11/09/2021
• Report Date (Section F): 11/09/2021

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 Lot Number: 1131930D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• 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: Female
• Patient Weight: 62 KG
• Date Report Sent to FDA: 11/09/2021