BD recalls 2 years' worth of bone marrow needle kits after 37 complaints

BD has begun a voluntary recall of many of its intraosseous needle kits and delivery systems, citing a handful of potential safety issues with the devices.

Inserted through the bone to quickly deliver drugs or fluids to the bloodstream via the bone marrow, the technique is used when a patient’s blood vessels can’t be reached by the traditional routes through central or peripheral veins, such as during cardiac arrest, severe shock and other emergency situations.

BD’s intraosseous needles can be driven through the bone using either a manual or powered device. The former relies on pressure from a hospital worker to send the needle through the bone, while the latter is more like a standard power drill, able to place the needle with the touch of a button.

In letters dated June 20, BD informed buyers and distributors of the devices that it had discovered manufacturing flaws in many of the needle kits—including those for both manual and powered drivers—and asked that they immediately destroy all affected kits and pause use of their drivers until BD has determined it’s safe to resume.

BD didn’t offer a total tally of the number of individual needle kits affected by the recall but listed more than six dozen batch numbers that are included in the safety notice. They were distributed beginning in late January 2020, with expiration dates ranging from September of this year through the end of 2024.

Those devices—spanning multiple needle sizes for each driver—were found to be at risk of three main safety issues. According to BD, users may have difficulty separating the stylet from the hollow needle; the safety mechanism may not automatically deploy as the stylet is removed; or the metal discs that are used to magnetically hold a needle in place within a powered driver may stay stuck to the magnet, keeping the needle from properly deploying.

Those issues could potentially cause a delay in urgently needed care, as they could either prevent a needle from being correctly inserted or, once in place, block the needle’s intravenous access. The lack of a safety mechanism could also lead to needle stick injuries.

So far, BD said it has received 37 complaints related to the identified safety issues, with no reports of serious injuries or death.

The company attributed the issues to flaws in the adhesive curing process used while manufacturing the needle kits. BD has yet to begin rolling out a replacement product, but said that “corrective actions are being implemented to prevent recurrence.”

Healthcare providers who use BD’s needle kits and their distributors have been asked to compare the lot numbers on their stores of the kits to those included in the recall, then throw out any that match. The company said its representatives will contact customers to inspect their manual and powered drivers and conduct any necessary repairs before giving the go-ahead to resume use.

If needle kits included in the recall have already been used or are still in use but are functioning properly, no follow-up procedures or mitigating steps need to be taken.

As for the destroyed devices, with no replacement products currently available, in the meantime, BD suggested that healthcare providers “evaluate their clinical needs and consider obtaining and using an alternative intraosseous product.”