FDA Warns of Possible Danger with Animal Vaccine Device
September 2, 2011
The Food and Drug Administration is warning veterinarians and pet owners, particularly cat owners, of the possible risk of fractures with the Vet Jet™ transdermal vaccination system device. The device, made by Bioject, Inc., is sold exclusively as the delivery system for the Merial product, PUREVAX® Recombinant Feline Leukemia Vaccine. The device delivers the leukemia vaccine through the skin to cats.
FDA is aware of three recent adverse event reports involving the use of the Vet Jetâ„¢ device in kittens. In two of the cases, the user failed or may have failed to properly lock the nozzle into the device before using it. The nozzle subsequently dislodged at the time of vaccination, causing a fracture of the femur (the thigh bone).
Merial is fully investigating the three cases. The company is also revising the “Instructions for Use†for the Vet Jet™ device to stress that users need to securely lock the nozzle into the device. In addition, Merial is sending a letter to all Vet Jet™ device users urging them to carefully follow the nozzle locking procedure.
FDA asks veterinarians and pet owners who want to report problems with the Vet Jetâ„¢ device to first contact Merial. They can also report problems to FDA by submitting FORM FDA 1932a1.
http://www.fda.gov/AnimalVeterinary/.../ucm270642.htm
September 2, 2011
The Food and Drug Administration is warning veterinarians and pet owners, particularly cat owners, of the possible risk of fractures with the Vet Jet™ transdermal vaccination system device. The device, made by Bioject, Inc., is sold exclusively as the delivery system for the Merial product, PUREVAX® Recombinant Feline Leukemia Vaccine. The device delivers the leukemia vaccine through the skin to cats.
FDA is aware of three recent adverse event reports involving the use of the Vet Jetâ„¢ device in kittens. In two of the cases, the user failed or may have failed to properly lock the nozzle into the device before using it. The nozzle subsequently dislodged at the time of vaccination, causing a fracture of the femur (the thigh bone).
Merial is fully investigating the three cases. The company is also revising the “Instructions for Use†for the Vet Jet™ device to stress that users need to securely lock the nozzle into the device. In addition, Merial is sending a letter to all Vet Jet™ device users urging them to carefully follow the nozzle locking procedure.
FDA asks veterinarians and pet owners who want to report problems with the Vet Jetâ„¢ device to first contact Merial. They can also report problems to FDA by submitting FORM FDA 1932a1.
http://www.fda.gov/AnimalVeterinary/.../ucm270642.htm
Thanks for the heads up.
