MAUDE Adverse Event Report: AMGEN INC. ONPRO KIT; INTRODUCER, SYRINGE NEEDLE

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta onbody device placed on patient prior to leaving infusion center.Placed to patient's left upper arm which is an approved area of administration per manufacturer.Overnight malfunction of adhesive, patient found device had fall off in her sleep.Required return to clinic for neulasta injection the next day.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 14986468
• Report Number: 14986468
• Device Sequence Number: 1547140
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/30/2022
• Report Date (Section F): 06/30/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 07/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2022
• 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 Race: White
• Date Report Sent to FDA: 06/30/2022