Early Alert: Intraosseous Needle Set Issue from Becton Dickinson

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.Affected Product The 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.Affected devices:Prodcut NameCatalog NumberUDI-DINeedle Kit for Powered Driver 15mm x 15GaD015151NK00801741163586Needle Kit for Powered Driver 25mm x 15GaD015251NK00801741163678Needle Kit for Powered Driver 35mm x 15GaD015351NK00801741163593Needle Kit for Powered Driver 45mm x 15GaD015451NK00801741163609Needle Kit for Powered Driver 55mm x 15GaD015551NK00801741163616Full list of affected lotsWhat to DoDo not use affected product. Identify and destroy all affected units in accordance with your facility’s process.On July 30, BD sent all affected customers a letter recommending the following actions:Please immediately discontinue use of the affected lot(s).

Check all inventory locations within your facility and destroy all affected needle set kits in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. For Clinical Users:The product that is impacted by this recall notification should not be used to establish IO access.Although IO access is an important option during resuscitation, unsuccessful IO placement does not necessarily represent exhaustion of all vascular access options.

Alternate vascular access approaches, including additional peripheral IV attempts, or central venous access may continue to be pursued based on clinical judgment and institutional protocols For patients in whom potentially affected intraosseous needles are currently in use and are functioning properly, no additional steps need to be taken. This issue occurs during insertion only.For patients in whom potentially affected intraosseous needles have been used and are now removed, no additional follow-up activities are required.For Distributors:Check all inventory locations within your facility and destroy all affected needle set kits in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.Identify all customers within your distribution network that purchased any affected product as defined in this notification.

A customer letter template is provided for you to create your own letter to be sent to all customers to advise them of this field action.Provide product replacement or credit for all product destroyed by your customer. BD will not provide any reimbursement (product replacement or credit) to your customers.Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertBD stated that some lots were manufactured with out-of-tolerance dimensions, and as a result some users have reported difficulty removing the obturator (stylet) following placement of the BD Intraosseous Vascular Access System Needle Sets.

Based on complaint reports, bench testing completed by BD and clinical observations, this may occur when pulling back on the drill during the insertion or when 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 specific lots of the product with out-of-tolerance dimensions.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 45 serious injuries and four deaths associated with this issue.Device UseThe BD Intraosseous Vascular Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.Contact InformationCustomers 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.Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.