MAUDE Adverse Event Report: INSULET CORPORATION NEULASTA; INJECTOR, PEN

Lot Number	1108606C
Health Effect - Clinical Code	Underdose (2542)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Pt called the hospital to inform that his neulasta on body injector had leaked out all over him.He's unsure how much of the medication he actually received.He said that some of the tape by the "green flashing light" was lifted up and that's where it had leaked from.He had removed the device and placed it in his own personal sharps container.He was placed on the schedule for a neulasta injection that same day.Upon arrival pt brought in the sharps container with 3 neulasta obis inside.He informed that 2 out of 3 injectors had leaked (this current one and the previous one).

• Brand Name: NEULASTA
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 9953037
• Report Number: 9953037
• Device Sequence Number: 11282031
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/19/2020
• Report Date (Section F): 02/19/2020

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
• Device Lot Number: 1108606C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/19/2020