MAUDE Adverse Event Report: AMGEN USA, INC. NEULASTA OBI; INTRODUCER, SYRINGE NEEDLE

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called on call provider to report that onpro was leaking.She stated that after the dose was delivered her arm was soaked so she did not know how much of the dose she got.Patient advised not to throw away the onpro.

• Brand Name: NEULASTA OBI
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 9510703
• Report Number: 9510703
• Device Sequence Number: 16524604
• Product Code: KZH
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/16/2019
• Report Date (Section F): 12/16/2019

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 the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/16/2019