Field Safety Notice Becton Dickinson BD BACTEC™ Plus Aerobic/F Culture Vials (ICN 2275)

• Alert:
• Becton Dickinson (BD) has issued a Field Safety Advisory Notice for specific Lots of BD BACTEC™ Plus Aerobic/F Culture Vials.
• BD has confirmed through two customer complaints that certain vials of the BD BACTEC™ Plus Aerobic/F Culture Vials have a labelling issue where duplicate barcode sequence numbers have been identified on more than one vial.
• In the rare occurrence that a site receives multiple affected Lots, this issue may result in culture vials with these duplicate sequence numbers being scanned into the BD BACTEC™ fluorescent series instruments.
• This event will cause a mis-association of patient blood culture results under certain, very limited conditions.
• BD advise that in the majority of scenarios, the instrument’s pop-up alerts will notify users of any vials that have duplicate sequence numbers which are already in or recently removed from the instrument. Built-in safeguards will also prevent users from re-entry of vials in some cases, minimising the risk of mis-association of patient results. However, if a vial is scanned into the BD BACTEC™ fluorescent series instruments with a duplicate sequence number to a vial removed within 0-5 hours prior, there is a risk of mis-association of patient data.
• Mis-association can lead to incorrect results being reported to the clinician, which could then lead to a delay or absence of appropriate diagnosis and treatment. Clinical implications of these adverse diagnostic outcomes range from mild to severe, depending on the clinical status of the patients involved and the specific manifestation of the error.

Products Affected:

•  This product is available from NHS Supply Chain:

• Please note only the Lot numbers quoted in Table 1 “Impacted Products” on page 1 of the Field Safety Notice are affected.
• BD is investigating and will implement appropriate measures to prevent any recurrence of this product issue.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Users should verify that the accession number on the BD Bactec™ Instrument loading screen matches the vial’s accession number while scanning and loading onto the instrument.
• If an error message or other system action occurs when loading vials into the BD Bactec™ Instrument that indicates a potential issue with duplicate sequence numbers, it is recommended to follow the instructions within the message and view the table of “System Alerts” located in “7-Troubleshooting” of the BD Bactec™ FX Instrument User’s Manual before taking any further action in vial processing. The link to the BD Bactec™ FX instrument User’s Manual is as follows:

https://eifu.bd.com/en/search/search-results?term=441385&cats=9444_,9441_9443,9441_9442,1185_,1185

• Complete and return the Customer Response Form on page 5 of the Field Safety Notice even if you no longer have any inventory remaining in your facility and email it to: BDUKFieldAction@bd.com
• If you have any questions about this, please contact your local BD representative or the local BD office on 0800 917 8776, or by emailing: BDUKFieldAction@bd.com
• BD advise there is no requirement for customers to return any BD BACTEC™ Plus Aerobic/F Culture Vials to BD, and that the products can continue to be used in accordance with the guidance in this Field Safety Notice.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or Customer Relationship Manager.

Please be aware that in the event of a Field Safety Notice or Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.