MAUDE Adverse Event Report: AMGEN/FLEXTRONICS INDUSTRIAL NEULASTA OBI; NEULASTA ON BODY INJECTOR

Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta on body injector malfunctioned an hour prior to administration being due.Pt then brought in for neulasta injection.Dates of use: (b)(6)2017.Diagnosis or reason for use: neutropenia.Is the product compounded: no.

• Brand Name: NEULASTA OBI
• Common Device Name: NEULASTA ON BODY INJECTOR
• Manufacturer (Section D): AMGEN/FLEXTRONICS INDUSTRIAL
• MDR Report Key: 6830197
• Report Number: MW5071821
• Device Sequence Number: 16128506
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2017

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 85