Potential for medication overdose with ENFit low dose tip syringes

October 13, 2021

The U.S. Food and Drug Administration (FDA) issued a safety communication informing patients and health care providers about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip (LDT) syringes.

The FDA is providing recommendations for patients and health care providers to promote the safe use of ENFit LDT syringes, including the steps users can take to optimize dose accuracy. When using the recommended steps included in the safety communication, the dose accuracy of the ENFit LDT syringes is equivalent to the dose accuracy of traditional syringes.

photo of ENFit Low Dose Tip Syringes

Recommendations for Health Care Providers, Patients, and Caregivers

To optimize dose accuracy using ENFit LDT syringes, users should:

  • Ensure the syringe is free of air bubbles and the moat of the syringe is free from fluids by tapping or flicking the tip of the syringe before administering the medication.
  • Use a filling adapter, such as an ENFit compatible cap or medication straw, to prevent fluid and medications from entering the moat area of the syringe tip.
  • Be aware that using a medicine cup to fill may cause fluid or medications to enter the moat of the syringe and lead to possible overdose.
  • Use a new syringe to flush the medication or fluid after administering any medication to prevent overdose due to the dead space (remaining fluid in the tip of the syringe after administration) in the syringe.

The FDA continues to recommend the use of enteral devices and syringes that reduce the risk of misconnections, such as ENFit LDT syringes.

Device Description and Background

To reduce the risk of misconnections and serious patient injuries and death, the FDA recommends use of enteral devices with connectors that meet the International Organization for Standardization (ISO)External Link Disclaimer 80369-1 or ISO 80369-3 standard or that are otherwise designed to reduce the risk of misconnections. There are currently marketed enteral connectors that follow the ISO 80369-3 standards, many of which are identified by the tradename ENFit.

ENFit LDT syri