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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 12/16/2016

Event Type  malfunction  

Event 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
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 7959739
• MDR Text Key: 123517781
• Report Number: 7959739
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA