Dive Brief:
- Becton Dickinson is recalling a range of products used to deliver fluids and medications during resuscitations and life-saving procedures because of problems that could lead to patient deaths.
- The recall affects 11 needle set kits, manual driver kits and powered drivers used in intraosseous delivery, which lets physicians access the vascular system via bone marrow in some emergency situations. Because patients who need intraosseous access are often critically ill, BD warned that delays in care caused by the device problems could lead to death.
- BD has received 37 complaints about the problems but no reports of serious injuries or deaths. In light of the risks, BD is asking customers to destroy affected devices and consider “obtaining and using an alternative intraosseous product” until the company can provide replacements.
Dive Insight:
BD gained the intraosseous assets in its $24 billion takeover of Bard, which is still listed as manufacturer of the devices in the Global Unique Device Identification Database. The Food and Drug Administration oversaw Class 2 recalls of BD intraosseous needles and aspiration trays last year but otherwise there has been little news about the products. BD received 510(k) clearance for an infusion system last year.
The FDA has yet to assign the recall to a risk category but BD said that, because the devices are used in patients with critical conditions such as cardiopulmonary arrest and severe shock, delayed care may cause outcomes ranging from “no health effects to progression/exacerbation of underlying illness to death.”
The recall affects lots distributed from late January 2020 onward. In those lots, the latest of which were manufactured in July 2021, the devices can suffer from one of three problems that may cause limited or nonfunctioning intraosseous access that delays urgent care.
In some cases, the healthcare provider may struggle to separate the stylet from the intraosseous needle, leading them to apply extra force that causes the “inadvertent removal of the entire needle assembly during placement or inability to remove the stylet from an indwelling intraosseous needle.” Both outcomes can cause “functional loss of intraosseous access.”
Other devices may feature needle safety mechanisms that fail to deploy after placement of the needle and removal of the stylet. On the powered drivers, metal discs may stick “unexpectedly” to the magnet, making it impossible to use the driver. BD has identified inadequate adhesive curing as the cause of the problems.
The company is working on corrective actions for the adhesive curing but has yet to provide a replacement product. While its products remain unusable, BD is asking customers to consider alternative devices. Cook Medical and Teleflex are among the other providers of intraosseous infusion needles
