MAUDE Adverse Event Report: SYRINGE; SYRINGE, PISTON

Device Problems Defective Device (2588); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous communication from the patient who reports that due to a defective whisperject autoinjector device, which jammed, the patient had to waste 2 syringes of glatiramer.She did not miss any doses but is requesting a new whisperject device and replacement of the 2 wasted syringes.There was no adverse event reported.It is unknown if the defective product/device is available for return.No further information was provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12744906
• MDR Text Key: 280478467
• Report Number: MW5105086
• Device Sequence Number: 2
• Product Code: FMF
• 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
• 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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: GLATIRAMER ACETATE (12X1ML)