MAUDE Adverse Event Report: NEULASTA ONPRO ON-BODY INJECTOR; INTRODUCER, SYRINGE, NEEDLE

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Neulasta onpro fell off.Patient was just sitting on couch and the device started beeping but it had fallen off and was beside him on the couch.Patient had showered early that day.Dates of use: (b)(6) 2017.Diagnosis or reason for use: prostate cancer.Is the product over-the-counter: no.

• Brand Name: NEULASTA ONPRO ON-BODY INJECTOR
• Common Device Name: INTRODUCER, SYRINGE, NEEDLE
• MDR Report Key: 6820663
• Report Number: MW5071801
• Device Sequence Number: 13195086
• Product Code: KZH
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 96