MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA INTRODUCER, SYRINGE NEEDLE; EPINEPHRINE AUTO INJECTOR

Lot Number 007G18AA

Device Problem Failure to Deliver (2338)

Patient Problem Missed Dose (2561)

Event Date 07/02/2020

Event Type  Injury  

Event Description

On july 2nd reporter had an anaphylactic reaction to a medication and tried using her epinephrine pen but the auto injector failed.

• Brand Name: INTRODUCER, SYRINGE NEEDLE
• Type of Device: EPINEPHRINE AUTO INJECTOR
• Manufacturer (Section D): TEVA PHARMACEUTICALS USA
• MDR Report Key: 10326516
• MDR Text Key: 200809065
• Report Number: MW5095738
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 007G18AA
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention