FDA Warning for Children with Enteral Feeding Sets
The U.S. Food and Drug Administration (FDA) issued a safety communication regarding children with enteral feeding sets. To access the full communication, click here.
Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets
The FDA released a public warning for children with enteral feeding sets. Children can become tangled in the tubing causing strangulation which can lead to injury or death.
There are two reported cases of toddlers that died from tube strangulation when they were left alone for approximately 10 minutes. The FDA acknowledges that this risk is low but understands that it is possible and has occurred.
Recommendations To Help Prevent the Potential Risk of Strangulation
- Know that there is a possible risk of strangulation from tubing.
- Do not leave the set where children can access it and become entangled.
- Talk with your doctor about preventative measures to ensure your child does not become entangled.
If you have further questions about this issue, talk with your doctor. To help improve patient safety, please report any incidents with strangulation to the FDA by completing their MedWatch Online Voluntary Reporting Form on their website.
FDA Evaluation and Future Prevention
The FDA is working to provide awareness of this potential risk, including informing all applicable parents, caregivers and healthcare professionals.
The FDA is also investigating factors that may have contributed to these cases to help prevent future incidents and is looking more into the possible risk in pediatric patients.
Reporting an issue
If you experienced an issue with your feeding tube set, please complete the MedWatch Voluntary Reporting Form.
If you have questions, please email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 1.800.638.2041 or 1.301.796.7100.
*The picture of the feeding set tubing located at the top of the page may look different than yours.
*Disclaimer: Any health and wellness content presented is for general informational purposes only. Such content is not intended to replace or serve as a substitute for professional medical advice, diagnosis or treatment.