This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
Bupivacaine Ampule
Example kit with Bupivacaine ampule identified in the red circle
The FDA is aware that Becton Dickinson & Company has issued a letter to affected customers recommending all anesthesia trays be corrected prior to continued use by removing the Bupivacaine ampules.
Affected devices:
- BD Spinal Tray with BD Whitacre Needle
- BD Spinal Tray with BD Quincke Needle
- BD Spinal Tray with Sprotte Needle
Full list of affected products
What to Do
Do not use Bupivacaine ampules from affected kits. All remaining components within the kits may continue to be used.
On April 27, Beckton Dickenson sent all affected customers a letter recommending the following actions:
- Do not use the Bupivacaine ampules contained within the affected products. The Bupivacaine ampule is the only impacted component within the tray and all remaining components can continue to be safely used.
- Secure an alternative local Bupivacaine drug prior to entering the procedural environment.
- Upon opening the kit, remove and destroy the drug product from the BD Anesthesia Tray at the point of use. All other kit components are safe to use.
- If affected Bupivacaine ampule was previously used without issue, no additional treatment or clinical follow up is required.
- If affected Bupivacaine ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions.
Reason for Correction
Becton Dickinson & Company stated Huons Co., Ltd. manufactured bupivacaine ampules were recalled due to quality issues identified during a recent FDA inspection and limited reports of drug ineffectiveness. These ampules are included in BD Spinal Trays. Risks of using compromised injectables include localized infection, inflammatory response or reduced anesthetic effectiveness.
As of April 27, Becton Dickinson has reported no serious injuries or deaths associated with this issue.
Device Use
The BD Regional Anesthesia Trays/Kits are intended for use by professional anesthesiologists to perform Spinal and/or Epidural or Nerve block anesthesia procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Becton Dickinson & Company at [email protected] or 1-844-823-5433.
Additional FDA Resources:
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 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.