Luer-Activated Valve Connector FDA Alert

FDA is alerting healthcare professionals that certain Luer-activated valve (LAV) connectors (sometimes referred to as needleless Luer access devices or needleless connectors) with internal pin designs may not be compatible with prefilled glass syringes. An agency notice says the internal pin of the LAV connector may break when attached to a prefilled glass syringe, causing the LAV connector to clog and prevent the administration of the drug.

“Incompatibility, particularly in emergency and urgent situations, can delay therapy and potentially result in serious harm to patients,” the notice says.

FDA previously issued a 3/2013 letter to stakeholders with an update on certain needleless prefilled syringes and a 4/2013 draft guidance for manufacturers to help address safety concerns for prefilled glass syringes with connecting devices, including LAV connectors.

The agency says it is continuing to work with device and drug manufacturers to mitigate the compatibility issues.