The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding specific lots of Becton Dickinson (BD) Intraosseous Vascular Access System Needle Sets, recommending their removal due to manufacturing defects. These needle sets were produced with out-of-tolerance dimensions, leading to reports of difficulty in removing the obturator (stylet) after placement.
BD identified that this issue can occur if users pull back on the drill during insertion, fail to pull straight back with the powered driver, or incorrectly rotate or try to unscrew the obturator. Such actions can cause the obturator-needle hub interface to rotate and lock, hindering removal.
Clinicians facing this problem may need to seek alternative vascular access, potentially delaying critical therapy. This delay poses a significant risk to critically ill patients, including those experiencing out-of-hospital cardiac arrest and severe trauma, and can result in serious injury or death.
As of July 22, BD has reported 45 serious injuries and four deaths associated with this issue. The FDA's Center for Devices and Radiological Health (CDRH) said it is issuing this alert "to notify the public of a potentially high-risk device issue" and will continue to update the public as new information becomes available.