Halyard 95656Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956566), received between Jun 19, 2018 and Jun 19, 2018 — 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. 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.

• MalfunctionJun 19, 2018Break; Break

  IT WAS REPORTED THAT A GASTROSTOMY-JEJUNOSTOMY (GJ) TUBE WAS RUPTURE ASSOCIATED WITH PATIENT USAGE. A MOTHER WAS FLUSHING THE PORT WITH WARM WATER AND SHE HEARD A "POP" SOUND. THE TUBE BECAME LOOSE SIMULTANEOUSLY. SHE CHECKED THE BALLOON AND THERE WAS NO WATER IN IT, SO SHE WENT TO THE RADIOLOGY DEPARTMENT TO HAVE IT REPLACED. WHEN A GUIDE WIRE WAS INSERTED INTO IT, IT WAS IMMEDIATELY VISUALIZED IN THE STOMACH. WHEN THE TUBE WAS REMOVED, IT WAS NOTICED THAT THERE WAS A TEAR ON THE J-TUBE SIDE. ADDITIONAL INFORMATION RECEIVED ON 31-MAY-2018 STATED THAT THE TUBE WAS IN PLACE FOR 19 DAYS. IT WAS REPLACED WITHOUT ISSUE AND WITHOUT INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 11-JUN-2018 FROM (B)(4) PRELIMINARY SAMPLE EVALUATION STATED THAT THE BALLOON HAD BURST AND THAT THE OUT WALL OF THE TUBE WAS RUPTURE AT THE GASTRIC SKIVES, WHICH CREATED A CROSS-LUMEN COMMUNICATION. DURING THE INITIAL CONTACTS WITH THE CUSTOMER, IT WAS NOT KNOWN THAT THERE WAS A TEAR ON THE ACTUAL FEEDING TUBE. IT WAS INITIALLY UNDERSTOOD THAT THE TEAR OCCURRED ON THE J-TUBE SIDE OF THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617802 ↗