Sam Brusco, Associate Editor08.11.22
The U.S. Food and Drug Administration (FDA) has identified BD’s (Becton Dickinson) recall of its intraosseous needle set kits, manual driver kits, and powered drivers as Class I.
2,207 drills and 34,355 needle sets were recalled in the U.S. beginning June 20. The products were distributed between January 20 and May 5 of this year.
BD’s intraosseous infusion system helps clinicians obtain access to blood vessels through the bone when care is needed but it’s difficult or impossible to obtain typical access intravenously. The access can then be used to administer medications or fluids.
BD recalled the products over three issues:
These problems can cause care delays over inability to place functional intraosseous access. The technique is used mostly in critically ill patients, including those with cardiopulmonary arrest or severe shock. Delats in care in these instances can cause serious injury or death.
2,207 drills and 34,355 needle sets were recalled in the U.S. beginning June 20. The products were distributed between January 20 and May 5 of this year.
BD’s intraosseous infusion system helps clinicians obtain access to blood vessels through the bone when care is needed but it’s difficult or impossible to obtain typical access intravenously. The access can then be used to administer medications or fluids.
BD recalled the products over three issues:
- The stylet might be difficult to separate from the needle or may not separate at all, resulting in inadvertent removal of the entire needle assembly during placement. The clinician may also be unable to remove the stylet from the needle. Both result in functional loss of intraosseous access.
- The needle safety mechanism might not deploy correctly when the style it removed from the needle after placement.
- Metal discs may stick in the powered driver, rendering it unusable.
These problems can cause care delays over inability to place functional intraosseous access. The technique is used mostly in critically ill patients, including those with cardiopulmonary arrest or severe shock. Delats in care in these instances can cause serious injury or death.