This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk 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 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:
| Product Description | Model Number | UDI-DI | Lot Numbers |
|---|---|---|---|
| Microbore Extension Set | V6215 | Case: 04046964189173 Each: 04046964189166 |
0061742452, 0061747379, 0061767411, 0061780914, 0061803499, 0061806173, 0061822333, 0061836578, 0061849109, 0061850836, 0061899902, 0061936368, 0061936119, 0061936369, 0061940584 |
What to Do
Identify and stop use of all affected product. Affected product should be quarantined and clearly labeled to prevent accidental use until it can be returned to B. Braun. Do not destroy affected product.
- On July 9, B. Braun Medical Inc. sent all affected customers a letter recommending the following actions:
- Review the Urgent Medical Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and any other concerned persons, are informed about this voluntary recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the hospital/healthcare facility level.
- Determine your current inventory of the affected items within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product.
- Utilizing the "Urgent Medical Device Recall Acknowledgement Form", record the total number of individual impacted units. If you have no inventory remaining, please enter zero (0) on the form.
- Return the completed "Urgent Medical Device Recall Acknowledgement Form" to the B. Braun Medical Inc. Postmarket Surveillance department.
- Once we receive your Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.
- 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 Alert
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.
Device Use
B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical Inc. at 1-833-425-1464.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved 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.
