Dive Brief:
- BD is recalling certain lots of intraosseous vascular access system needle sets due to a problem associated with four deaths, according to a Food and Drug Administration early alert posted Tuesday.
- The needles are used to provide access to the bone marrow in emergency care situations when intravenous access is difficult. BD said in a statement last week that certain lots were manufactured with out of tolerance dimensions and may be more difficult to remove after placement.
- BD reported four deaths where inability to remove the stylet occurred during resuscitation efforts for cardiac arrests. The company has received 75 complaints, including 45 serious injury reports.
Dive Insight:
BD sent customers a letter on July 30 instructing them to identify and destroy all affected units.
The company found that people may have difficulty removing the stylet based on complaint reports, bench testing and clinical observations. For needles manufactured with incorrect dimensions, certain actions can allow rotation and locking where the obturator and needle meet.
If this happens, clinicians may need to get a new intraosseous infusion needle or another vascular access device, which can delay the start of therapy. Critically ill patients who need urgent vascular access, such as out-of-hospital cardiac arrest and severe trauma patients, are at the greatest risk.
BD said the affected lots were manufactured between September 2024 and June 2026. Devices distributed outside of that window are not affected. BD said it has identified the root cause of the problem and has taken actions, such as product and labeling improvements, to reduce the likelihood of recurrence.
The FDA said it is reviewing the problem and will inform the public as significant new information becomes available.
