MAUDE Adverse Event Report: AMGEN USA, INC. SURECLICK; INTRODUCER, SYRINGE NEEDLE

Model Number	NDC 72511-760-02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The injector did not retract after the shot was given.I have photos - and did call the manufacturer, but the nurse spent over half hour going through safety protocols, warnings and everything listed on their instruction sheets which i did not need and did not really listen to my concern.I thought the needle may have retracted, but it did not click when it was finished - and looking at it carefully.It was sticking out 1/4" from the injection level.Even though the window was yellow (and likely all medicine was injected) i had to pull the needle out of my skin.No bad side effects a day after, but it is a concern if the needles do not work properly.I gave them the lot number, and requested a sharps container.It took about 45 minutes to deal with them on the phone.Repatha injector - malfunction.No second click and needle did not retract.Fda safety report id # (b)(4).

• Brand Name: SURECLICK
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr. ; louisville KY 40299
• MDR Report Key: 12136316
• Report Number: MW5102351
• Device Sequence Number: 14170459
• Product Code: KZH
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Occupational Therapist
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: Lay User/Patient
• Device Model Number: NDC 72511-760-02
• Device Lot Number: 1128374
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 61