Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc.
The FDA is aware that B. Braun Medical Inc. has issued a letter to affected customers recommending certain microbore extension sets be removed from where they are used or sold.
The affected Microbore Extension Sets labels show incorrect information about the device’s filter. Specifically, the product label shows that the device contains an air eliminating filter. However, the filter used on this extension set does not feature an air vent, which is common to air eliminating filters, and is not indicated for the removal of air.
If during use there is air within the line or filter itself, the air can occlude the filter. This could lead to a significant delay in therapy with significant impact on patient condition (e.g. with life sustaining drugs). It is possible for air to escape the filter and enter the patient where embolization could occur. This could lead to patient harm up to and including permanent organ damage or death.
As of July 9, B. Braun Medical Inc. has not reported any serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Questions?
Customers in the U.S. with questions about this recall should contact B. Braun Medical Inc. at 1-833-425-1464.
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