MAUDE Adverse Event Report: AMGEN INC. / IMMUNEX CORPORATION ENBREL MINI; INJECTOR, PEN

Lot Number	1120570
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pt reports defective device that the needle got stuck and dose was not administered.Patient received a sample from the md, so she didn't miss her dose."unknown if." reported to (b)(6) by pt/caregiver.

• Brand Name: ENBREL MINI
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): AMGEN INC. / IMMUNEX CORPORATION ; one amgen ctr dr. ; thousand oaks CA 91320 1799
• MDR Report Key: 11506807
• Report Number: MW5100052
• Device Sequence Number: 3699749
• Product Code: NSC
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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 Expiration Date: 03/01/2023
• Device Lot Number: 1120570
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1
• Patient Age: 58 YR