MAUDE Adverse Event Report: AMGEN PEGFILGRASTIM ONPRO ON BODY INJECTOR, 6MG SYRINGE; SYRINGE, PISTON

Lot Number	A403830006476
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
On body injector with pegfilgrastim applied on (b)(6) 2017; pt reported on (b)(6) 2017 am that the device failed to inject medication.Red light flashing; no leakage from device; device gauge indicates full.Pt returns to have manual injection (b)(6) 2017.Dates of use: (b)(6) 2017.Diagnosis or reason for use: neutropenia prevention.

• Brand Name: PEGFILGRASTIM ONPRO ON BODY INJECTOR, 6MG SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): AMGEN
• MDR Report Key: 6756547
• Report Number: MW5071313
• Device Sequence Number: 1693484
• Product Code: FMF
• 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): 07/28/2017

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
• Device Lot Number: A403830006476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2017
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 58