FDA Class I Recall: Becton Dickinson Intraosseous Needle Set Kits, Manual Driver Kits, Powered Drivers

Aug. 12, 2022

The FDA has identified Becton Dickinson’s recall of Intraosseous Needle Set Kits, Manual Driver Kits, and Powered Drivers as a Class I recall, the most serious type of recall.

Use of these devices may cause serious injuries or death.

Recalled Product

Product Name: BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, BD Intraosseous Powered Drivers

Product Codes: See recall database entry

Devices Recalled in the U.S.: 2,207 drills and 34,355 needle sets

Dates distributed: January 20, 2020, to May 5, 2022

Date Initiated by Firm: June 20, 2022

Device Use

The BD Intraosseous Infusion System is used by clinicians to obtain access to blood vessels through a patient’s bone (intraosseous) when emergency, urgent, or medically necessary care is needed but it is difficult or impossible for the clinicians to obtain typical access through the blood vessels (intravenously). This access can then be used to inject or infuse medications/fluids. It is used in both adults and children for up to 24 hours.

Reason for Recall

Becton Dickinson is recalling the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, and BD Intraosseous Powered Drivers for three separate issues:

The stylet may be difficult to separate from the needle or may not separate at all. This may result in inadvertent removal of the entire needle assembly during placement, or the clinician may be unable to remove the stylet from the needle, both resulting in functional loss of intraosseous access.

The needle safety mechanism may not properly deploy as the stylet is removed from the intraosseous needle after placement.

Metal discs may stick in the powered driver, which may render it unusable.

These issues can cause delays in care due to the inability to place functional intraosseous access. Since intraosseous access is most often used in critically ill patients, including those with cardiopulmonary arrest or severe shock, the potential delays in care can cause serious injury or death. There is also the risk of needle stick injury.

There have been 37 complaints with no serious injuries or deaths reported associated with these recall issues.

Who May Be Affected

Healthcare providers who place the BD Intraosseous Infusion System to deliver treatments to adults or children.

Patients who may need to receive an intraosseous device from the BD Intraosseous Infusion System.

What to Do

On June 20, 2022, Becton Dickinson issued an Urgent Medical Device Recall letter recommending customers:

·       Quarantine all affected devices.

·        Destroy affected needle kits.

·        Do not use affected powered drivers until a Sales Representative states it is safe to use. Sales Representatives will reach out to schedule a visit to inspect the powered driver(s) and repair if required.

·        Share recall information with all users within the facility’s network and with any organization where affected products may have been transferred.

·        Be aware there is no replacement product at this time. Consider obtaining and using an alternative intraosseous product. Becton Dickinson will notify customers when replacement products are available.

·        For products purchased from BD: Complete a Customer Response form (included with the letter) whether or not impacted products remain.

·        For products purchased from a distributor: Contact the distributor for further instructions, if applicable.

The letter also notes that there are no necessary follow-up activities when potentially affected intraosseous needles:

·        Have already been used and are now removed.

·        Are currently in use and are functioning properly.

FDA release