|
The U.S. Food and Drug Administration (FDA) is aware that Becton Dickinson (BD) has issued a letter to affected customers recommending certain Intraosseous Vascular Access System Needle Sets be removed from where they are used or sold. BD noted that some lots were manufactured with out-of-tolerance dimensions, which has resulted in some users reporting difficulty in removing the obturator (stylet) following the placement of BD Intraosseous Vascular Access System Needle Sets.
The firm has discovered that this may occur when pulling back on the drill during insertion, failing to pull straight back with the powered driver, or incorrectly rotating or trying to unscrew the obturator. These actions allow the rotation and locking of the obturator-needle hub interface for these specific lots.
If rotation and locking occurs, the clinician may need to obtain a new IO needle or other form of vascular access device, such as a Peripheral IV catheter, which may result in a delay to therapy initiation. Patients at greatest risk are critically ill individuals requiring urgent vascular access, including out-of-hospital cardiac arrest and severe trauma patients. Delay to initiate therapy can result in serious injury or death.
As of July 22, BD has reported four deaths and 45 serious injuries associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact BD at productcomplaints@bd.com or call (844) 823-5433.
|
