Halyard 95660Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956603), received between Jan 31, 2017 and Jan 31, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2017Break; Break

  IT WAS REPORTED THAT AN INCIDENT OCCURRED WHILE AN INFANT WAS BEING CHANGED. A PORTION OF THE FEEDING TUBE PASSED THROUGH THE INFANT'S FECES. THE PROXIMAL PORTION OF THE FEEDING TUBE REMAINED IN THE STOMACH AND THE PART THAT WAS SEVERED PASSED THROUGH THE INFANT¿S INTESTINES INTO THEIR FECES. THE TUBE APPEARED TO HAVE BEEN CUT. THE INFANT WAS TAKEN TO INTERVENTIONAL RADIOLOGY TO REPLACE THE TUBE. THE DEVICE WAS ORIGINALLY PLACED (B)(6) 2016. THERE WERE NO INJURIES, AND THE INFANT DID NOT EXHIBIT ANY SIGNS OR SYMPTOMS OF DISTRESS PRIOR TO THE DISCOVERY OF THE TUBE FOUND IN FECES. ADDITIONAL INFORMATION RECEIVED 17-JAN-2017 STATED THE FEEDING TUBE WAS ONE DEVICE THAT WAS IN TWO PIECES. THERE WAS THE PIECE THAT REMAINED IN THE STOMACH THAT APPEARED TO BE CUT AND THE PORTION THAT WAS SEVERED THAT MIGRATED THROUGH THE INTESTINE. EVEN THOUGH THE DEVICE WAS IN TWO PIECES, BOTH PIECES ARE FROM THE SAME DEVICE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6290268 ↗