MAUDE Adverse Event Report: TEVA NEUROSCIENCE / OWEN MUMFORD USA INC. AUTO-INJECTOR; INTRODUCER, SYRINGE NEEDLE

Device Problems Break (1069); Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Therapy start date unknown, dispensed prior to acs; who gave you information? patient; what is the complaint about the product? the copaxone auto injector malfunctioned twice.On (b)(6) 2022 it broke the syringe and the dose was not given.On (b)(6) 2022, it again broke the syringe, and a partial dose was given; was the product taken or administered? on (b)(6) 2022 it was not given, on (b)(6) 2022 a partial dose was given -unknown if patient experienced any side effects; what is the lot number? pt does not have lot number or expiration date; can the manufacturer call the patient for follow up if necessary? yes; can the manufacturer arrange for product pick up? yes; md aware and drug therapy continues unchanged.Reported to cvs/caremark by pt/caregiver.

• Brand Name: AUTO-INJECTOR
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): TEVA NEUROSCIENCE / OWEN MUMFORD USA INC.
• MDR Report Key: 15799127
• MDR Text Key: 303730163
• Report Number: MW5113238
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: COPAXONE
• Patient Sex: Female