BD Intraosseous Needle Kit Recall Issued Over Risk of Serious Injury or Death

The BD Intraosseous Needle Kit recall follows nearly 40 complaints of problems

Following dozens of complaints involving problems with intraosseous needle kits, Becton Dickinson has recalled thousands of drills and tens of thousands of needle sets used to access blood vessels in patients’ bones being removed from the market.

The FDA announced the BD Intraosseous Needle and Driver Kit recall on August 11, giving it a Class I designation, which suggests that continued use of the product may pose a risk of serious injury or death.

Becton Dickinson first reported problems with the kits in June, after identifying at least 37 complaints reported. However, the manufacturer maintains that no injuries or deaths have been reported in relation to the recalled needle kits.

Problem with BD Intraosseous Needle Kits

BD intraosseous needle kits and powered drivers are used by doctors to gain access to blood vessels through a patient’s bone when emergency, urgent, or medically necessary care is needed. It is done when it is difficult or impossible for the doctor to obtain typical access through the blood vessels, requiring them to enter through bone (intraosseous).

Intraosseous access is most often used in critically ill patients, including those with cardiopulmonary arrest or severe shock. This recall can lead to potential delays in care that can cause serious injury or death to critically ill patients. It also poses a risk of needle stick injury.

The recall was initiated due to three separate issues. First, the stylet may be difficult to separate from the needle or may not separate at all. This can lead to inadvertent removal of the entire needle assembly during placement, or the doctor may be unable to remove the stylet from the needle, leading to loss of intraosseous access or function loss.

Second, the needle safety mechanism may not properly deploy as the stylet is removed from the intraosseous needle after placement. Third, metal discs may stick in the powered driver, which may render it unusable.

The recall impacts Becton Dickinson Intraosseous Needle Set Kits, Intraosseous Powered Driver Kits, and Intraosseous Powered Drivers distributed between January 20, 2020, to May 5, 2022. An estimated 2,207 drills and 34,355 needle sets are affected.

Becton Dickinson sent an urgent medical device recall letter to customers on June 20, calling for customers with affected devices to quarantine them, destroy affected needle kits, and urging them not to use affected powered drivers until a Sales Representative can determine they are safe to use.

The manufacturer also called for customers to share recall information with other users. Becton Dickinson also warns that there are no replacements for these products at this time and urged customers to obtain and use an alternative intraosseous product.