Halyard 95649Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956498), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

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

• MalfunctionJan 19, 2018Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE FEEDING TUBE WAS EXCHANGED DUE TO LEAKAGE AND THE TUBE COMING OUT. UPON EXAMINATION, THE DOCTOR NOTICED THAT THE G PORT WAS ON THE J PORTION OF THE TUBE, AND THE J PORT WAS ON THE G PORTION OF THE TUBE. THE PARENTS DENIED SWITCHING OR TAMPERING WITH THE PORTS. PER ADDITIONAL INFORMATION RECEIVED ON 15 JAN 2018, THE FEEDING TUBE WAS IN PLACE FOR 86 DAYS AND THERE WAS NO KNOWN ADVERSE AFFECTS ON THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 18 JAN 2018, THE MOTHER OF THE PATIENT STATED THAT THE TUBE BEGAN LEAKING FROM THE GASTRIC PORT SEVERAL WEEKS AGO, AND EVENTUALLY THE TUBE CAME OUT PART WAY. THE MOTHER PUSHED IT BACK IN PLACE AND PUT MORE WATER IN THE BALLOON. ON INITIAL INSPECTION, THE CLOSURE DEVICE THAT USUALLY CLOSED THE GASTROSTOMY AND JEJUNOSTOMY PORT WAS NO LONGER PRESENT ON THE TUBE. IN ADDITION, THE ANTERIORLY FACING PORT WAS LABELED GASTROSTOMY AND THE LATERAL FACING PORT WAS LABELED JEJUNOSTOMY, THE OPPOSITE OF WHAT IS NORMALLY SEEN WITH THESE TUBES. THE MOTHER DID NOT SPECIFICALLY REPORT THAT THE PORTS CAME LOOSE AND WERE REPLACED. THE FEEDING TUBE WAS EXCHANGED UNDER FLUOROSCOPIC GUIDANCE. PRIOR TO THE EXCHANGE, THE PHYSICIAN INJECTED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207071 ↗