Monoject 406SERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521512849), received between Dec 2, 2019 and Dec 2, 2019 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A NASOGASTRIC TUBE RUPTURED RESULTING IN A PATIENT ASPIRATING. THE NASOGASTRIC TUBE INVOLVED IN THE INCIDENT WAS FROM ANOTHER MANUFACTURER (AVANOS - 10FR FINE BORE NASOGASTRIC CORPAK PUR FEEDING TUBE). THE SYRINGE USED TO FLUSH THE BLOCKED TUBE WAS A CARDINAL HEALTH 6ML ENFIT SYRINGE. IT WAS REPORTED THAT THERE WERE SEVERAL FACTORS INVOLVED IN THIS INCIDENT AND THE CUSTOMER IS UNABLE TO IDENTIFY EXACTLY WHAT CAUSED THE RUPTURE; THE TUBE HAD BEEN IN PLACE FOR 6 WEEKS, THE PATIENT HAD A GASTROSCOPY PROCEDURE WHILE THE TUBE REMAINED IN PLACE, AND POST PROCEDURE THE TUBE BECAME BLOCKED SO THE NURSE FLUSHED THE TUBE WITH COKE USING THE CARDINAL HEALTH ENFIT 6ML SYRINGE TO UNBLOCK THE TUBE. THE FEEDING WAS RECOMMENCED AND SUBSEQUENTLY THE PATIENT ASPIRATED. WHEN THIS WAS IDENTIFIED, THE FEEDING WAS CEASED AND THE TUBE WAS REMOVED, WHICH WAS WHEN THE RUPTURE WAS DISCOVERED. THE PATIENT WAS A CRITICALLY UNWELL PATIENT AND PASSED AWAY 12 DAYS LATER. THE CUSTOMER REPORTED THAT IT IS NOT BELIEVED THAT THIS INCIDENT CAUSED THE DEATH BUT MAY HAVE CONTRIBUTED TO THE PATIENT¿S FURTHER DETERIORATION. IT WAS REPORTED THAT THE OTHER MANUFACTURER'S (AVANOS) INSTRUCTION FOR

  Patient problems: Aspiration/Inhalation; Death

  MAUDE report 9396881 ↗