The FDA’s Center for Devices and Radiological Health issued an early alert for Becton Dickinson’s Intraosseous Vascular Access system needle sets in the wake of four deaths and 45 serious injuries.
A CDRH early alert is a warning from the regulatory agency for patients and physicians not to use a medical device that has the potential for high-risk outcomes before a formal recall classification is determined.
BD issued a recall letter on July 30 stating that use of the needle sets be discontinued immediately and that all affected lots be destroyed or quarantined until disposal, the agency said in its alert.
Intraosseous (IO) systems are primarily used in emergency medicine to drill through either the tibia or humerus bones in order to deliver large volumes of fluids such as blood, Ringer’s lactate and saline as well as critical drugs to trauma patients.
The company’s recall was based on complaints, observations and testing by BD that indicated difficulties in removing the stylet following placement by a physician or clinician.
“This may occur when pulling back on the drill during the insertion or when failing to pull straight back with the powered driver or incorrectly rotating or trying to unscrew the obturator,” the company said in a statement. “These actions allow the rotation and locking of the obturator-needle hub interface for specific lots of the product with out-of-tolerance dimensions.”
The patients most at risk from the IO system are critically ill and require urgent vascular access, including out-of-hospital cardiac arrest and severe trauma patients.
The number of deaths and serious injuries connected to the faulty IO system was through July 22, the company said.
The regulatory agency said it will continue to review the situation and will issue new information when it becomes available.
Editor's Note: The original headline stated that there were four deaths connected to this recall. This has been changed in relation to a request from BD.