Devices

FDA Warns of High-Risk Issue With BD Intraosseous Needle Sets

FDA has issued an early alert warning healthcare providers not to use certain Becton Dickinson (BD) intraosseous vascular access needle sets after the company identified a manufacturing defect that has been linked to delays in establishing emergency vascular access, including reports of four deaths and 45 serious injuries.

The alert follows a 7/30 field action by BD instructing customers to immediately stop using and destroy affected lots of five models of its BD Intraosseous Vascular Access System Needle Sets. The affected products include 15 mm, 25 mm, 35 mm, 45 mm and 55 mm, 15-gauge needle kits used with powered drivers to obtain emergency intraosseous access when intravenous access is difficult or impossible.

According to FDA, BD determined that certain lots were manufactured with out-of-tolerance dimensions that can make it difficult to remove the obturator, or stylet, after needle placement. The problem may occur if the drill is pulled back during insertion, if the powered driver is not withdrawn straight back, or if the obturator is rotated or unscrewed, allowing the obturator and needle hub to lock together.

If the device cannot be disengaged, clinicians may need to obtain another intraosseous needle or use an alternative vascular access device, such as a peripheral intravenous catheter, potentially delaying treatment. FDA said patients at greatest risk include critically ill individuals requiring immediate vascular access, including those experiencing out-of-hospital cardiac arrest or severe trauma, where delays in therapy could result in serious injury or death.

The BD Intraosseous Vascular Access System is indicated for emergency intraosseous access in adult and pediatric patients when intravenous access cannot be readily obtained and may be used for up to 24 hours.

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