Field Safety Notice MDS-21-4144 BD SmartSite® Needle Free Valve : Recommendation steps to be followed prior to clinical use of the needle-free connector.

 

Affected Medical Device : SmartSite®Extension Set

 

MDA Reference Number : MDA/FCA/2021-P127

 

MDA Registration Number : GB34415890818

 

Decription : BD has identified potential issues with the valve of the Needle-free Connector for the products listed in this Fi eld Action resulting in difficulty to flush, flow issues, and partial or total occlusions on the Extension Sets with SmartSite™ and Standalone SmartSite™ connectors.

 

Local Establishment Contact Detail :

Patricia Netto
Regulatory Affairs , Senior Executive
No 6, Changkat Semantan, Damansara Heights,Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 50490
t: 603.20938788

Email : Patricia.Netto@bd.com

 

 A copy of FSN.