MAUDE Adverse Event Report: AMGEN USA, INC. NEULASTA ON-BODY; INTRODUCER, SYRINGE NEEDLE

Lot Number	0160161
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported the device came off when clothes were taken off.

• Brand Name: NEULASTA ON-BODY
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr.; louisville KY 40299
• MDR Report Key: 20521586
• Report Number: 20521586
• Device Sequence Number: 20365535
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/18/2024
• Report Date (Section F): 10/18/2024

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: Lay User/Patient
• Device Lot Number: 0160161
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/18/2024