The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.
The Food and Drug Administration (FDA) issued an early alert to notify the public of a high-risk issue involving certain Becton Dickinson Intraosseous Vascular Access System Needle Sets. The warning follows reports of manufacturing defects that have led to serious injuries and patient deaths.
Becton Dickinson notified customers that some lots were manufactured with out-of-tolerance dimensions. This defect can cause the obturator, also known as a stylet, to rotate and lock into the needle hub during insertion. When this occurs, clinicians may face difficulty removing the obturator, necessitating the use of a new needle or an alternative form of vascular access.
As of July 22, Becton Dickinson has reported 45 serious injuries and four deaths associated with this issue.
“Although IO [intraosseous] access is an important option during resuscitation, unsuccessful IO placement does not necessarily represent exhaustion of all vascular access options,” reads a release from Becton Dickinson, the manufacturer. The company notes that alternate approaches, including peripheral intravenous attempts or central venous access, should be pursued based on clinical judgment.
Patients at the greatest risk are critically ill individuals requiring urgent vascular access, such as those experiencing out-of-hospital cardiac arrest or severe trauma. A delay in therapy initiation caused by the device failure can result in serious injury or death.
On July 30, Becton Dickinson sent a letter to affected customers recommending they immediately discontinue the use of affected lots. Healthcare facilities are advised to identify and destroy all affected units according to their internal processes. If destruction is not immediately possible, the products should be quarantined until disposal.
For patients in whom a potentially affected needle is currently in use and functioning properly, no additional steps are required. Becton Dickinson states the issue occurs during the insertion process only.
The affected products include several needle kits for powered drivers, including:
- Needle Kit for Powered Driver 15mm x 15Ga
- Needle Kit for Powered Driver 25mm x 15Ga
- Needle Kit for Powered Driver 35mm x 15Ga
- Needle Kit for Powered Driver 45mm x 15Ga
- Needle Kit for Powered Driver 55mm x 15Ga
Distributors are also instructed to check all inventory locations, destroy affected kits, and notify customers within their distribution network who purchased the products. Distributors are instructed to provide product replacement or credit for all product destroyed by customers, as Becton Dickinson notes it “will not provide any reimbursement (product replacement or credit) to your customers.”
The Becton Dickinson Intraosseous Vascular Access System is designed to provide access in the proximal tibia, distal tibia, and humeral head of adult and pediatric patients, and the distal femur in pediatric patients. It is used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases.
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