The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death.
- Product Name: BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, BD Intraosseous Motorized Driver
- Product codes: see recall database entry
- Devices recalled in the United States: 2,207 drill bits and 34,355 needle sets
- Air dates: January 20, 2020 to May 5, 2022
- Date of initiation by the company: June 20, 2022
Use of the device
The BD Intraosseous Infusion System is used by clinicians to access blood vessels through a patient’s bone (intraosseous) when emergency, urgent, or medically necessary care is needed, but it is is difficult or impossible for clinicians to obtain typical access through blood vessels. (intravenously). This access can then be used to inject or infuse medications/fluids. It is used in adults and children for up to 24 hours.
Reason for recall
Becton Dickinson is recalling BD Intraosseous Needle Kits, BD Intraosseous Manual Driver Kits and BD Intraosseous Electric 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 the needle assembly being inadvertently removed during placement, or the clinician may be unable to remove the stylet from the needle, both leading to functional loss of intraosseous access.
- The needle safety mechanism may not deploy properly when the stylet is removed from the intraosseous needle after placement.
- Metal discs can get stuck in the powered driver, which can render it unusable.
These issues can lead to delays in care due to the inability to place a functional intraosseous access. Since intraosseous access is most often used in critically ill patients, including those with cardiorespiratory arrest or severe shock, potential delays in care may result in serious injury or death. . There is also a risk of needlestick injury.
There have been 37 complaints with no reported serious injuries or fatalities associated with these recall issues.
Who can be affected
- Healthcare providers who place the BD Intraosseous Infusion System to administer 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 advising customers:
- Quarantine all affected devices.
- Destroy the affected needle kits.
- Do not use the affected electrical drivers until a sales representative has declared them safe to use. Sales representatives will contact you to schedule a visit to inspect the motorized driver(s) and repair if necessary.
- Share the recall information with all users on the facility network and with any organization where the affected products may have been transferred.
- Please note that there is no replacement product at this time. Consider obtaining and using another intraosseous product. Becton Dickinson will notify customers when replacement products become available.
- For products purchased from BD: Complete a Customer Response Form (included with the letter), whether or not any affected product remains.
- For products purchased from a distributor: Contact the distributor for further instructions, if any.
The letter also notes that there are no follow-up activities required when potentially affected intraosseous needles:
- Have been used before and are now removed.
- Are currently in use and working properly.
Customers with questions or concerns about this recall should contact Becton Dickinson’s North American Regional Complaint Center by phone at 1-844-8BD-LIFE (1-844-823-5433); say “call back” when prompted or email [email protected]
How do I report a problem?
Healthcare professionals and consumers can report any adverse reactions or quality issues they have encountered while using these devices to MedWatch: the company’s safety information and adverse event reporting program. FDA using an online form, mail or fax.