AVANOS 20-9366Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770457857), received between Oct 22, 2020 and Nov 12, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS NOTED AT 10PM THAT THERE WAS MILK COMING OUT FROM NEAR THE HUB OF THE FEEDING TUBE. THE PATIENT WAS RECEIVING SERUM GLUCOSE AT 50MG/DL ON CONTINUOUS ORAL DIGESTIVE TUBE (ODT) FEEDING, 12ML/HOUR. THE PATIENT'S SERUM GLUCOSE WAS "AT 30'S AT START OF SHIFT DUE TO ODT NEEDED TO BE REINSERTED AND VERIFIED BY X-RAY" AT 7PM. PATIENT HAS HISTORY OF HYPOGLYCEMIA. DUE TO THE LEAK, A NEW TUBE WAS ATTEMPTED TO BE INSERTED BY A NEONATAL NURSE PRACTITIONER (NNP), TWICE, UNSUCCESSFULLY. INSTEAD THE TUBE WAS PLACE NASOGASTRICALLY (NGT), AND PLACEMENT WAS CONFIRMED WITH X-RAY. SERUM GLUCOSE WAS THEN MONITORED EVERY 15 MINS, EVERY 30 MINS THEN HOURLY X2 UNTIL STABLE. SERUM GLUCOSE STABILIZED WHEN NGT FEEDING RESUMED. PER ADDITIONAL INFORMATION RECEIVED 5 NOV 2020, THE ODT HAD BEEN IN PLACE FOR 1 3/4 HOURS PRIOR TO THE FEEDING TUBE LEAKING.

  Patient problems: No Code Available

  MAUDE report 10829800 ↗
• DeathOct 22, 2020Burst Container or Vessel; Fracture; Material Split, Cut or Torn; Burst Container or Vessel; Fracture; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED (B)(6) 2020 INDICATED THAT DURING SURGICAL REPAIR OF THE BOWEL, IT WAS NOTED THAT THE FEEDING TUBE WAS FRACTURED BUT NOT BROKEN IN TWO; A SLIT WAS NOTED IN THE TUBE AND REMAINED IN ONE PIECE.

  Patient problems: Bowel Perforation; Laceration(s)

  MAUDE report 10719204 ↗