Hazard description
Some lots were manufactured with out-of- tolerance dimensions, and as a result some users have reported difficulty removing the obturator (stylet) following placement of the BD Intraosseous Vascular Access System Needle Sets. Based on complaint reports, bench testing completed by BD and clinical observations, 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. These actions allow the rotation and locking of the obturator-needle hub interface for specific lots of the product with out-of-tolerance dimensions.