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

Lot Number	1133524
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Spontaneous: patient reported that 2 of the 4 pens in his shipment from (b)(6) 2021 did not work correctly.When he went to inject the dose, the needle went into skin, but no medication came out.The needle did not retract after removing from skin.Confirmed with patient that the white cap was removed before injecting.The patient missed two doses due to this failure.Referred patient to the manufacturer (b)(4).Reported to (b)(6) by pt/caregiver.

• Brand Name: ENBREL SURECLICK PF AUTOINJECTOR
• Common Device Name: INJECTOR, PEN
• Manufacturer (Section D): AMGEN INC. / IMMUNEX CORPORATION; one amgen center drive; thousand oaks CA 91320 1799
• MDR Report Key: 12861928
• Report Number: MW5105533
• Device Sequence Number: 5339543
• 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): 11/19/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/01/2024
• Device Lot Number: 1133524
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male