Bard Tri-Funnel Replacement Gastrostomy Tube 000718Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741037146), received between Jun 10, 2016 and Feb 11, 2022 — classified as 4 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2022Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LEAK AND THE BALLOON WAS NOT INFLATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13511738 ↗
• InjuryAug 11, 2021Inflation Problem; Defective Component; Inflation Problem; Defective Component

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD DEFECTIVE COMPONENT AND INFLATION PROBLEM. THE PROCEDURE WAS COMPLETED BY A SURGICAL INTERVENTION. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12306350 ↗
• InjuryJul 16, 2021Burst Container or Vessel; Disconnection; Fluid/Blood Leak; Fracture; Device Dislodged or Dislocated; Burst Container or Vessel; Disconnection; Fluid/Blood Leak; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TEN DAYS POST DEVICE PLACEMENT, THE FEEDING TUBE ALLEGEDLY CAME OUT OF THE DEVICE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS RUPTURED AND EXTRAVASATION WAS NOTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN

  Patient problems: Extravasation

  MAUDE report 12178985 ↗
• MalfunctionSep 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE DAY AFTER FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY HAD INFLATION VALVE MALFUNCTION AND THE BALLOON WAS DEFLATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584898 ↗
• MalfunctionAug 11, 2020Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED AND A STERILE WATER LEAKAGE WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389633 ↗
• MalfunctionJul 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY SIXTEEN DAYS POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY LEAK FROM THE ENTRANCE WHEN THE BALLOON IS INFLATED. REPORTEDLY, ANOTHER DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269339 ↗
• MalfunctionJun 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST FEEDING DEVICE PLACEMENT, THE BALLOON ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157481 ↗
• MalfunctionMay 28, 2020Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE PREPARATION, DURING INFLATING THE BALLOON, AN ALLEGED LEAK OF WATER WAS FOUND PRIOR TO USE ON PATIENT WHICH RENDERED THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10099254 ↗
• MalfunctionApr 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST FEEDING DEVICE PLACEMENT, THE PROBE WAS PASSED BUT THE BALLOON DOES NOT REMAIN FILLED. IT WAS FURTHER REPORTED THAT A SUBTLE LEAK WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916226 ↗
• MalfunctionOct 29, 2019Deflation Problem; Device Dislodged or Dislocated; Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY FIVE DAYS POST FEEDING TUBE IMPLANT, THE TUBE ALLEGEDLY DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251304 ↗
• MalfunctionOct 23, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE IMPLANT, THE BALLOON ALLEGEDLY RUPTURED, RESULTING IN THE CATHETER FALLING OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225835 ↗
• MalfunctionJul 25, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000718 REPLACEMENT GASTRONOMY TUBE ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE INVOLVED PATIENT WAS REPORTED TO BE FEMALE WITHOUT AGE OR WEIGHT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827820 ↗
• InjuryMay 28, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT WITHIN AN HOUR OF FEEDING DEVICE PLACEMENT, THE FEEDING TUBE ALLEGEDLY DISLODGED OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT UPON INSPECTION, THE BALLOON WAS INFLATED AND A PIN HOLE SIZED LEAK WAS ALLEGEDLY IDENTIFIED. REPORTEDLY, THE PATIENT UNDERWENT ANESTHESIA AND ANOTHER FEEDING TUBE WAS PLACED DAYS LATER. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 8647859 ↗
• MalfunctionMay 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE DAY POST FEEDING DEVICE PLACEMENT, THE FEEDING TUBE ALLEGEDLY DISLODGED OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT ANOTHER FEEDING TUBE WAS PLACED DAYS LATER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647244 ↗
• MalfunctionApr 17, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 000718 FEEDING DEVICE REPORTED THAT THE BUTTON GASTROSTOMY REPLACEMENT FEEDING TUBE ALLEGEDLY EXPERIENCED IMPROPER OR INCORRECT PROCEDURE OR METHOD. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO REPORTED PATIENT INJURY. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525542 ↗
• MalfunctionDec 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE FEEDING TUBE ALLEGEDLY DISLODGED FROM THE PATIENT. IT WAS FURTHER ALLEGED THE PATIENT IS EXPERIENCING STOMACH IRRITATION DUE TO MULTIPLE REPLACEMENTS. REPORTEDLY, THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189424 ↗
• MalfunctionDec 21, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT AN ALLEGED HOLE WAS IDENTIFIED ON THE FEEDING TUBE. IT WAS FURTHER ALLEGED THE PATIENT IS EXPERIENCING STOMACH IRRITATION DUE TO MULTIPLE REPLACEMENTS. REPORTEDLY, THE DEVICE WAS REPLACED. IT WAS FURTHER REPORTED, THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189380 ↗
• MalfunctionDec 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE FEEDING TUBE ALLEGEDLY DISLODGED FROM THE PATIENT. IT WAS FURTHER ALLEGED THE PATIENT IS EXPERIENCING STOMACH IRRITATION DUE TO MULTIPLE REPLACEMENTS. REPORTEDLY, THE DEVICE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189342 ↗
• MalfunctionJun 14, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND 27 DAYS THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER FEEDING TUBE WAS PLACED. THE PATIENT WAS REPORTED AS BEING STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602936 ↗
• MalfunctionJun 6, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE WAS OBSERVED NEXT TO THE TUBE WHEN INSERTING WATER. THE LEAKAGE WAS BETTER OBSERVED WHEN PRESSING THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7574741 ↗
• MalfunctionMay 24, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PEG TUBE ALLEGEDLY FELL OUT OF PLACEMENT AND THE BALLOON FAILED TO MAINTAIN INFLATION. IT WAS FURTHER ALLEGED THAT THE HEALTHCARE PROVIDER PLACED ANOTHER PEG TUBE. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543371 ↗
• MalfunctionMay 24, 2018Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PEG ALLEGEDLY TUBE FELL OUT OF PLACEMENT AS A RESULT OF FAILING TO MAINTAIN INFLATION. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543329 ↗
• MalfunctionMay 24, 2018Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PEG TUBE ALLEGEDLY FELL OUT OF PLACEMENT AND THE BALLOON WAS DEFLATED. A NEW DEVICE WAS PLACED. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543285 ↗
• MalfunctionMar 29, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE GASTROSTOMY TUBE LEFT SPONTANEOUSLY, DUE TO THE BALLOON BEING DAMAGED. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383314 ↗
• MalfunctionDec 21, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND REMAINED IN THE PATIENT, REQUIRING REMOVAL. ANOTHER CATHETER WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140512 ↗