BD Announced Voluntary Recall for Intraosseous Products

Becton, Dickinson and Company (BD), a pioneer in medical technology, has issued a voluntary recall notice for a trio of their intraosseous access products.

Intraosseous infusion of a drug is when a drug is administered into the bone marrow cavity which facilitates the delivery of the drug through a non-collapsible vein. The intraosseous infusion concept was created in 1922 by Dr. Cecil K. Drinker who noted that bone (specifically the sternum) can be used to administer fluids for emergency reasons in addition to the intravenous (IV) route. This technology is mainly employed when the access to the IV system is limited or inaccessible for drug delivery due to reasons such as obesity, burns, fluid retention and drug abuse.

Intraosseous infusion is reliable as it can aid in the delivery of a drug in a short time and has a great success rate in the first attempt. This method has been used for the following: enabling a prompt fluid infusion, quick drug delivery in cardiac resuscitation and replenishment of blood cells.

Becton, Dickinson and Company (BD), a pioneer in medical technology, has issued a voluntary recall notice for a trio of their intraosseous access products.

BD did not immediately respond to Xtalks’ request for comment.

Reasons for BD’s Recall on Intraosseous Products

BD has announced the voluntary recall of their following products: BD™ Intraosseous Needle Set Kits, BD™ Intraosseous Manual Driver Kits, and BD™ Intraosseous Powered Drivers. They have warned that their products within expiration date can cause the following issues:

• The operational loss of the intraosseous system as it could be difficult to separate the stylet from the intraosseous needle. If increased force is applied for the removal of the stylet from the intraosseous needle, this may result in the damage of the overall needle assembly.
• The failure in the deployment of the needle safety mechanism on the stylet after placement of the intraosseous needle and removal of the stylet from the needle.
• The driver may become defective because the metal discs intended to connect the needle assembly to the magnet in the powered driver stick unexpectedly to the magnet.

Outcomes of the Recall

The sudden recall of the products may result in medical care delay or limited access to medical care. BD has warned that continuing to use its recalled products may result in needlestick injuries. The professionals who currently use the intraosseous products are advised to keenly check the recall notice.

BD has stated that their representatives will be reaching out to customers for inspection and will repair the devices if required. BD has also stated that there are no current replacements available from BD, and that customers should assess their clinical needs and consider obtaining and using an alternative intraosseous product.

BD’s Intraosseous Products

BD’s Intraosseous Vascular Access System was designed to have the following components: a needle (15mm, 25mm, 35mm, 45mm or 55mm lengths), a needle hub, a stylet tip safety, a stylet, a driver adapter hub and a powered driver. The position of the needle should be aligned at a 90-degree angle to the skin before the insertion. The powered driver then helps the needle penetrate the bone, and this insertion can also be done manually by rotating the needle in a clockwise or counterclockwise direction by applying a moderate steady pressure.

The intraosseous access sites for the device are in the proximal humerus, proximal tibia and distal tibia in adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is hard or impossible to get in emergent, urgent, or medically necessary cases for up to 24 hours.