Halyard 95640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651956405), received between Apr 18, 2017 and Sep 20, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED A CROSS-LUMEN BREACH OCCURRED ON THE JEJUNAL FEEDING TUBE. THE INTERNAL SEPTUM WAS COMPROMISED, ALLOWING JEJUNAL FEEDING TO EXIT THE GASTRIC SKIVES.

  Patient problems: No Information

  MAUDE report 7893951 ↗
• MalfunctionNov 29, 2017Break; Break

  IT WAS REPORTED THAT A PATIENT HAD TO HAVE A REPLACEMENT TUBE BECAUSE THE ORIGINAL BROKE IN TWO PIECES BETWEEN THE BALLOON AND THE EXTERNAL BOLSTER OF THE GASTRIC-JEJUNAL TUBE. THERE WAS NO INJURY TO THE PATIENT, BUT THE PATIENT HAD TO RECEIVED GENERAL ANESTHESIA AND A SCOPE TO REMOVE THE BROKEN TUBE. ADDITIONAL INFORMATION RECEIVED ON 13-NOV-2017 STATED THAT THE TUBE WAS PLACED ON (B)(6) 2017 AND THE INCIDENT OCCURRED ON (B)(6) 2017. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. HOWEVER, AFTER THE REMAINED OF THE TUBE WAS REMOVED BY ENDOSCOPE UNDER GENERAL ANESTHESIA, THE PATIENT HAD TO STAY ONE NIGHT IN THE PEDIATRIC INTENSIVE CARE UNIT UNDER OBSERVATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7066973 ↗
• MalfunctionJun 29, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT'S MOTHER TRIED TO CONNECT THE FEED TO THE TRANSGASTRIC-JEJUNAL TUBE AND NOTED THAT THE EXTERNAL PORTION OF THE TUBE WAS LYING IN THE PATIENT'S LAP AND THE REMAINDER OF THE TUBE WAS NO LONGER VISIBLE, AND ASSUMED TO BE INSIDE THE PATIENT'S STOMACH. THE PATIENT WAS BROUGHT TO HOSPITAL AND AN X-RAY CONFIRMED THAT THE TUBE WAS IN THE STOMACH AND SMALL BOWEL. APPROXIMATELY 30CM OF TUBING HAD BROKEN OFF INTO THE PATIENT'S GI SYSTEM. AN INTERVENTIONAL RADIOLOGY PROCEDURE WAS UNSUCCESSFUL AT RETRIEVING THE DEVICE. A NEW DEVICE WAS PLACED AND DAILY X-RAYS WERE PERFORMED TO TRACK THE PROGRESS OF THE BROKEN TUBING. THE PATIENT SUCCESSFULLY PASSED THE TUBE UNASSISTED AND WAS DISCHARGED HOME. NO RESIDUAL EFFECTS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 12 JUN 2017, IT IS UNKNOWN HOW LONG THE TUBE WAS IN USE PRIOR TO BREAKAGE. THE TIME IT TOOK FOR THE PATIENT TO PASS THE DEVICE WAS 3 DAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6678809 ↗
• MalfunctionApr 18, 2017Break; Break

  IT WAS REPORTED THAT A TRANSGASTRIC-JEJUNAL FEEDING TUBE BROKE AT THE ADAPTER AND FELL INTO THE PATIENT'S GASTRO-INTESTINAL TRACT. THIS REQUIRED THE PATIENT TO HAVE AN ADDITIONAL PROCEDURE TO REMOVE THE TUBE WHICH INCLUDED 15-MINUTES OF FLUOROSCOPY TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501393 ↗