Halyard 95480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651954807), received between Mar 6, 2017 and Apr 12, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED 12-APR-2019 STATED, IT IS WAS UNDERSTOOD THE PROCEDURE WAS A ROUTINE TUBE CHANGE. THE DEVICE IS CHANGED EVERY 3 TO 4 MONTHS. NO SPECIFIC PROBLEMS WERE NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8509107 ↗
• DeathAug 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY WIFE OF THE PATIENT TO THE DISTRIBUTOR THAT THE PATIENT¿S FEEDING TUBE HAD COME OUT AND HAD COILED INSIDE THE PATIENT. PER THE WIFE, THE RADIOLOGIST HAD TOLD HER THAT PER FLUOROSCOPY TESTING, THE DYE INSERTED INTO THE GASTRIC PORT WAS GOING INTO THE DUODENUM, AND THE DYE INSERTED IN THE JEJUNAL PORT WAS GOING INTO THE GASTRIC LUMEN. THE PATIENT PASSED AWAY ON (B)(6) 2017, AND THE WIFE ALLEGES THAT THE PATIENT WAS NOT GETTING THE PROPER FEEDING. THE WIFE ALSO REPORTS THAT THE PATIENT FELL TWICE AND HAD BLEEDING IN THE BRAIN, AND SLEPT MORE THAN USUAL. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2017 FROM DR (B)(6), FROM INTERVENTIONAL RADIOLOGY, THERE WAS NO MALFUNCTION OF THE TUBE THAT WAS REMOVED FROM THE PATIENT. THE MISFEEDING OF THE DYE WAS DUE TO THE INCORRECT POSITION OF THE TUBE INSIDE THE PATIENT, AS IT HAD COILED INSIDE THE PATIENT¿S STOMACH, RATHER THAN IN THE JEJUNUM. THE MEDICATION (UNKNOWN) THAT WAS BEING GIVEN TO THE PATIENT WAS SUPPOSED TO BE DELIVERED TO THE JEJUNUM FOR APPROPRIATE ABSORPTION, BUT WAS NOT GIVEN PROPERLY DUE TO THE INCORRECT POSITIONING OF THE FEEDING TUBE. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2017, A NURSE INVOLVED IN THE REP

  Patient problems: Death

  MAUDE report 6788102 ↗
• InjuryMar 6, 2017Break; Blocked Connection; Break; Blocked Connection

  IT WAS REPORTED ON 14-FEB-2017 THAT A FDA USER FACILITY REPORT (B)(4) WAS RECEIVED ON 03-FEB-2017 AND THE DATE OF THIS REPORT WAS 17-JAN-2017. IT WAS REPORTED THAT A PATIENT'S TRANSGASTRIC JEJUNAL TUBE WAS INFUSING TUBE FEED ALL NIGHT. THE KANGAROO PUMP ALL ALARMED CLOG IN LINE. THE NURSE ATTEMPTED TO FLUSH THE LINE WITH TOOMEY SYRINGE AND MET A SMALL AMOUNT OF RESISTANCE. PULSATILE FLUSHING WAS ATTEMPTED AND THE SIDE WALL OF LINE "POPPED" AND THE LINE WAS CLAMPED OFF. UPON REMOVAL, THE TUBE WAS FOUND TO BE IN THE ESOPHAGUS AND BOTH TUBE AND BALLOON WERE SEVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382573 ↗