FDA Alerts Health Care Professionals of Compatibility Issues with Prefilled Glass Syringes and Certain Luer-Activated Valve (LAV) Connectors

TOPIC: FDA Alerts Health Care Professionals of Compatibility Issues with Prefilled Glass Syringes and Certain Luer-Activated Valve (LAV) Connectors

AUDIENCE: Health Professional, Patient, Surgery

ISSUE: 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.

 Prefilled glass syringes have a smaller internal diameter tip that may not be compatible with LAV connectors that have an internal pin design. FDA has not received reports of compatibility issues when LAV connectors without an internal pin are used with prefilled glass syringes. In March 2013, FDA issued a Letter to Stakeholders: Update on certain needleless pre-filled glass syringes, identifying an FDA-approved needleless prefilled syringe with modifications to address some of the connectivity concerns with Luer access devices. The letter also provided a list of LAV connectors that are compatible with the approved needleless glass prefilled syringe.

 In April 2013, FDA issued a draft guidance for manufacturers to help address safety concerns for prefilled glass syringes used with connecting devices, including LAV connectors. The agency is evaluating this safety issue as we finalize the guidance.

 FDA is continuing to work with device and drug manufacturers to mitigate these compatibility issues. FDA requested applicable LAV connector manufacturers update their labeling to warn LAV connectors with an internal pin may not be compatible with prefilled glass syringes.

For more information about this recall/alert, click on the red button “Read Alert” below.

BACKGROUND: LAV connectors eliminate the use of needles and reduce needlestick injuries during intravenous administration of fluids and medication. FDA previously alerted health care professionals of similar compatibility issues with prefilled glass syringes containing adenosine or amiodarone. FDA recently received reports of compatibility issues with additional drugs available in prefilled glass syringes not identified in the agency’s previous alerts. The agency also determined the continuing compatibility issues are associated with LAV connectors with internal pin designs.  

RECOMMENDATIONS: 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 if LAV connectors in your medical supply stock are designed with an internal pin or post. Check the LAV connectors instruction for use or contact the manufacturer with questions.
• Stock emergency rooms, ambulances, and crash carts with drugs supplied in vials or prefilled plastic syringes, if necessary. Alternatively, consider using LAV connectors that do not use an internal pin.
• If your facility uses both LAV connectors with an internal pin and drugs packaged in prefilled glass syringes, establish and implement a plan to ensure safe administration of drugs.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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