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

Lot Number	A50118 0050180
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta on-body injector was administered to patient's right upper arm on [redacted] at approximately 1440 after administration of chemotherapy.Patient called on [redacted]-the following day, reported activating device but instantly receiving an error and loud beeping.Device showed full dose remained and none was administered.Pharmacist spoke with nurse coordinator and confirmed no gcsf [granulocyte colony-stimulating factor] was administered as a result of device failure.

• Brand Name: ONPRO KIT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 25093221
• Report Number: 25093221
• Device Sequence Number: 12966245
• 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): 04/20/2026
• Report Date (Section F): 04/20/2026

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
• Device Lot Number: A50118 0050180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 05/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/20/2026