Becton Dickinson UK BD Smartsite Needlefree Connection Products (ICN 1330)

Important Customer Notice Field Safety Notice

Ref: 2021/1330 ICN Number: 1330

MHRA TBC

NHSSC: 37

Alert:

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.

Products 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.

Next Steps:

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.

1330 Appendix 1
A PDF of the Appendix 1 for ICN 1330.
1330 Becton Dickinson Field Safety Notice
A PDF of the Field Safety Notice for ICN 1330.