AVANOS 44567Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770445670), received between Sep 29, 2022 and Dec 1, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Misconnection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryDec 1, 2023Misconnection; Misconnection

  IT WAS REPORTED THE PATIENT UNDERWENT A RADICAL TOTAL GASTRECTOMY ON (B)(6) 2022, WITH JEJUNOSTOMY FEEDING TUBE INSERTED INTO THE JEJUNUM DIRECTLY THROUGH THE SKIN ON THE ABDOMEN. THE PATIENT WAS "DIAGNOSED WITH INTRAABDOMINAL SEPSIS AND SMALL BOWEL PRESSURE NECROSIS CAUSED BY PRESSURE FROM THE FEEDING JEJUNOSTOMY BALLOON AND 21ML OF FLUID WAS FOUND IN THE BALLOON." A COMPUTED TOMOGRAPHY (CT) WAS COMPLETED THAT WAS HIGHLY SUSPICIOUS FOR BOWEL ISCHEMIA. PATIENT HAD A LAPAROTOMY, WASHOUT, REMOVAL OF FEEDING JEJUNOSTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. A REVIEW FOUND THAT AT SOME TIME DURING ADMISSION (TIME UNABLE TO BE DETERMINED) A SYRINGE WAS INSERTED INTO THE BALLOON PORT INSTEAD OF THE FEEDING PORT AND A WATER FLUSH ENTERED THE BALLOON, INFLATING IT TO 21MLS. THE INFLATED BALLOON WAS IMMOBILE AND EXERTED PRESSURE ON THE SMALL INTESTINE WALL WHICH CAUSED SMALL BOWEL PRESSURE NECROSIS AND LOCALIZED PERITONITIS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18245590 ↗
• DeathSep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED, AND THE PATIENT REMAINED IN THE HOSPITAL DUE TO OTHER NEEDS. IT WAS ADDITIONALLY REPORTED, THE FEEDING TUBE WAS FLUSHED UNDER PRESSURE AND HAD A LEAK JUST BELOW THE CONNECTOR ON THE TUBE; THE REPORTER CONFIRMED THERE WAS NO BLOCKAGE IN THE TUBE. THE PATIENT REPORTEDLY DIED. ADDITIONAL INFORMATION RECEIVED 09SEP2022 REPORTED, THE DEVICE REMAINED INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15505621 ↗