Date Issued: February 8, 2022

The U.S. Food and Drug Administration (FDA) is warning health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing. 

Recommendations for Parents and Caregivers of Children who Use Enteral Feeding Delivery Sets

  • Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death. 
  • To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled.
  • Discuss with your child's health care provider:
    • If your child has been tangled in their tubing before.
    • Steps you can take to help ensure that tubing does not get wrapped around your child’s neck, such as keeping the tubing away from the child as much as possible.
    • Any other concerns you may have about the risk of strangulation from feeding set tubing. 
  • If your child is injured by feeding set tubing, please report the event to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Health Care Providers

  • Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding delivery sets, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible.
  • When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety.
  • If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Device Description 

Enteral feeding delivery sets are medical devices used to provide nutrition to people who are unable to eat, swallow, or be fed by mouth to fully meet their nutritional needs. These sets include tubing that delivers feeding to the patient’s enteral tube (or feeding tube) using gravity or a pump. A feeding tube passes directly to the stomach or small intestine through the nose, mouth, or artificial opening in the abdomen. 

Picture of feeding set tubing. Your feeding set tubing may look different.

Potential Risk of Strangulation with Enteral Feeding Set Tubing Used in Children

The FDA received two death reports of strangulation with enteral feeding set tubing that occurred in 2021. Both reports involve children under the age of two found with tubing wrapped around their necks after a brief period of time (described as about 10 minutes in one report) when their caregivers were not directly monitoring them. 

While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur. It is also possible that some cases have not been reported to the FDA.

FDA Actions

The FDA is informing parents, caregivers and health care providers of this risk to children who receive enteral feeding, while we work with external stakeholders to increase awareness of the issue. 

The FDA is also working with manufacturers to evaluate information about the risk in pediatric patients, including follow-up with health care providers, parents and caregivers, to evaluate factors which may have contributed to the reported events of patient death as well as strategies to minimize patient risk.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. 

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.