MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS INC. WHISPERJECT; INTRODUCER, SYRINGE NEEDLE

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Mylan prescription whisper ject (auto-injector device) does not handle the needle cap removal properly.This was reported immediately to mylan (case # (b)(4)), with supporting documentation and photos, followed by additional telephone discussions, (thus this report is hopefully redundant to mylan's report).After the syringe is inserted into the auto-injector and the device locked, one pulls the needle cap remover from the device, which removes the needle cap form the syringe.The needle cap is supposed to fall free out of the needle cap remover.Instead the needle cap gets stuck inside the needle cap remover.The auto-inject dev ice cannot be reused unless the needle cap is removed from the needle cap remove.Procedures in the whisperject needle "instructions for use" manual (ifu:wject:r1), step 7b, do not dislodge the needle cap.Plainly, the mylan glatiramer acetate 20 mg daily injection syringes needle caps are larger than what the mylan whisperject needle cap remover is built to handle (whether by design or by manufacturing error).It is not clear if the fundamental problem is with a design non-complaint syringe, non-complaint auto-injector, or if this is a basic common design error.Fda safety report id # (b)(4).

• Brand Name: WHISPERJECT
• Common Device Name: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): MYLAN PHARMACEUTICALS INC.
• MDR Report Key: 9117890
• Report Number: MW5090012
• Device Sequence Number: 11337196
• Product Code: KZH
• UDI-Device Identifier: 00303789300324
• UDI-Public: 00303789300324
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: No Information
• Type of Report: Initial
• Report Date (Section B): 09/21/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 77