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

Lot Number 1134697

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient reported product complaint for enbrel.Device malfunctioned (b)(6) 2021 the needle did not come out of the pen and bubbles appeared.No dose was administered.No additional information to provide at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: ENBREL SURECLICK PF AUTOINJECTOR
• Type of Device: INJECTOR, PEN
• Manufacturer (Section D): AMGEN INC. / IMMUNEX CORPORATION; one amgen center dr.; thousand oaks CA 91320 1799
• MDR Report Key: 12737963
• MDR Text Key: 280053918
• Report Number: MW5105067
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2024
• Device Lot Number: 1134697
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR