Halyard 44066Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Continuous Feed Extension Set with ENFit® Connectors, SECUR-LOK* Right Angle Connector, 2 Port "Y" ENFit® Connectors and Clamp, 30 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651440666), received between Apr 5, 2019 and Apr 5, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Disconnection1
Patient problems
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2019Disconnection; Disconnection
IT WAS REPORTED BY THE PATIENT'S PARENTS THAT THEIR SON, WHO HAS TYPE 1A GLYCOGENOSIS, WOKE UP SCREAMING AND IN A STATE OF CONVULSION. THE CHILD'S BLOOD SUGAR WAS 0.18. THEY FOUND THAT THE EXTENSION SET ATTACHED TO THE CONTINUOUS FEED HAD BROKEN AWAY FROM THE GASTRIC BUTTON AT SOME POINT IN THE NIGHT. THEY CALLED EMERGENCY SERVICES. PER ADDITIONAL INFORMATION RECEIVED 27 MAR 2019, THERE WAS NO NEED FOR SURGERY. THE PATIENT IS BACK TO THE SAME STATUS HE WAS PRIOR TO THE INCIDENT. THE PARENTS REPORT THAT THERE WAS NO VISIBLE DEFECT TO THE EXTENSION SET. THE CONTINUOUS FEEDING MACHINE THAT WAS USED DURING THE INCIDENT WAS A NUTRICIA FLOCARE INFINITY, AND THE DEVICE WAS WORKING NORMALLY AND DOES NOT ALARM WHEN THE FEED LEAKS ON TO THE BED.
Patient problems: Hypoglycemia
MAUDE report 8486606 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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