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FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes

UPDATE [1/12/2018] Becton-Dickinson (BD) informed FDA that it is no longer using the rubber stopper material associated with loss of drug potency in its general use syringes , and BD has instead returned to a rubber stopper it used previously in the syringes . In 2015, FDA initially alerted health care professionals not to administer compounded and repackaged drugs stored in certain sizes of general use BD syringes, based on reports of an interaction with the rubber stopper that caused some drugs stored in these syringes to lose potency when not used immediately. As we stated previously, the general use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products, and we have not established the suitability of these syringes (wi...

FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors

[11/22/2022] FDA is alerting health care 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 (e.g., naloxone prefilled glass syringes). The internal pin of the LAV connector may break when attached to a prefilled glass syringe, causing the LAV connector to clog and prevent administration of the drug. Incompatibility, particularly in emergency and urgent situations, can delay therapy and potentially result in serious harm to patients. To help prevent potential risk to patients, FDA recommends health care professionals: Be aware compatibility issues may occur with prefilled glass syringes used with LAV connectors with an internal pin. Determine...