Halyard 44181Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651441819), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 18, 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.

• MalfunctionDec 15, 2016Connection Problem; Connection Problem

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE CAP ON THE DEVICE CAME OPEN AND THE FORMULA LEAKED OUT. THE PATIENT WAS NORMALLY ON AN OVERNIGHT CONTINUOUS FEED, BUT ON THE DAY OF THE EVENT, THE MOTHER HAD PUT THE PATIENT ON A DAYTIME CONTINUOUS FEED. THE MOTHER LEFT THE ROOM AND, UPON RETURNING AT ONE POINT, FOUND THE FORMULA LEAKING OUT OF THE SECOND PORT OF THE DEVICE, WHICH HAD COME UNCAPPED. THE MOTHER RESET THE FEED FOR THE FULL AMOUNT AGAIN, WITHOUT INCIDENT. THE MOTHER ALLEGES THAT THE PATIENT'S CONDITION, WHICH WAS NOT DISCLOSED, MAKES IT DANGEROUS FOR THE PATIENT TO GO WITHOUT THE FORMULA. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6175136 ↗