MAUDE Adverse Event Report: AMGEN USA, INC. NEULASTA ONPRO KIT; THERMOMETER, ELECTRONIC, CLINICAL

Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received neulasta onpro kit and noted the following day that his sleeve was soaked where the onpro device was.Patient called the neulasta company to report this.Patient was given a sq injection of neulasta due to losing some of the dose due to the leakage.

• Brand Name: NEULASTA ONPRO KIT
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 7959739
• Report Number: 7959739
• Device Sequence Number: 10970872
• Product Code: FLL
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2018
• Report Date (Section F): 09/21/2018

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?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2018
• 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: 09/21/2018