Becton Dickinson UK BD Smartsite Needlefree Connection Products (ICN 1330)
Important Customer Notice Field Safety Notice
Ref: 2021/1330 ICN Number: 1330
- Becton Dickinson UK (BD) has issued an advisory Field Safety Notification for specific lots of the BD Smartsite Needlefree connection products.
- BD has identified potential issues with the valve of the needlefree connector which results in difficulty to flush, flow issues and partial or total occlusions on the Extension Sets with SmartSite™ and Standalone SmartSite™ connectors.
- Only the lot numbers listed in Appendix 1 of the Field Safety Notice are affected by this issue.
- BD has an online tool to support the identification of impacted lot numbers. Please see our Useful Links section.
- There are nine NHS Supply Chain Codes affected:
|NPC||Product Description||Supplier Code/NPC||Route|
|FSW165||Needlefree connector / valve SmartSite L/2.5cm P/0.1 L/F||2000E7D||Stocked|
|FSB396||Needlefree extension set Y-connector set 2 x SmartSite valves 2 x S/C L/23cm P/0.6ml 1mm id L/F||20019E7D||Stocked|
|FSB893||Needlefree extension set Extension withJloop and SmartSite needle free valve L/15cm P/0.2 1mm id L/F||20021E7D||Stocked|
|FSB024||Needlefree extension set Extension line with SmartSite valve S/C L/13cm P0.3ml 1mm id L/F||20039E7D||Stocked|
|FSB399||Needlefree bag spike Bag device spike with SmartSite valve L/8.33cm P/0.46ml L/F||2300E||Stocked|
|FSB565||Needlefree bag spike Bag device spike with B/C SmartSite valve L/12.5cm P/0.86ml L/F||2309E-0006||eDirect|
|FKA329||Administration set Alaris GP Volumetric pump Burette set u/v spike 2 x Roll/C 2 R/C Alaris safety clamp 1 x SmartSite Y-port L/270cm P/38ml 3mm id L/F||60103E||Stocked|
|FSB854||Administration set Ivac Signature Edition pump Burette set 150ml v/u spike RC 1 x SmartSite Y-port L/297cm P/17ml 2.7id L/F||72103E-0006||Stocked|
|FSB831||Administration set gravity burette Add on 150ml burette set v/u spike Roll/C R/C SmartSite port spike port outlet L/56cm 2.7mmL/F||82113E-0006||eDirect|
- Please see our Downloads ▼ section to refer to the Field Safety Notice and Appendix 1 for further information on the affected product codes and Lot numbers.
- Read and follow the full instructions* in the Field Safety Notice and share with all users of the affected products.
- As a result of the feedback BD have received, and to mitigate the occurrence of the connector occluding, BD is recommending the following steps* be followed prior to clinical use of the needle-free connector.
- Depress the syringe plunger whilst the syringe is still attached to the needle-free connector.
- If unable to depress the plunger, pull back on the syringe plunger and depress the syringe plunger again. Repeating this step may assist in opening the needle-free connector valve.
- If the valve still is not open; without disconnecting the syringe male luer tip from the BD SmartSite™ valve surface, carefully unthread and rethread the syringe to partially disengage and reengage the syringe.
- Repeating this step up to three times may assist in opening the needle-free valve.
- Note: To maintain sterility, do not allow the syringe and needle-free valve to completely disconnect.
- If previous steps do not open the valve, then replace with another BD SmartSite needle-free connector.
- After the steps above, proceed with the existing instructions for use for product.
- Complete the customer response form on page 4 of the Field Safety Notice and return it to BDUKFieldAction@bd.com as soon as possible or no later than 31 August 2021. If you no longer use the product, it is still important that you return the Customer Response Form for our reconciliation purposes.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.