Bard Tri-Funnel Replacement Gastrostomy Tube 000716Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741037139), received between Mar 29, 2017 and Apr 11, 2022 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2022Break; Fluid/Blood Leak; Migration; Break; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT NEXT DAY POST FEEDING TUBE PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY CAME OUT AND HAD LEAK ISSUE. IT WAS FURTHER REPORTED THAT THE CUFF ALLEGEDLY FOUND TO BE RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14071242 ↗
• MalfunctionOct 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12629903 ↗
• MalfunctionMar 23, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO THE GASTROSTOMY TUBE PLACEMENT PROCEDURE, THE PHYSICIAN ALLEGEDLY NOTICED THE PRINTING ERROR OF THE DEVICE'S OUTER PACKAGE. THE TOP OF THE OUTER PACKAGE WAS ORANGE AND THE SIDES OF THE PACKAGE WERE YELLOW, ALTHOUGH 16FR IS SUPPOSED TO BE ORANGE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548509 ↗
• MalfunctionAug 12, 2020Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY FORTY-FOUR DAYS POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395094 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY TWENTY-NINE DAYS POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394676 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY TWENTY-ONE DAYS POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394675 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN DAYS POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394658 ↗
• MalfunctionJun 23, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, THE MEDICATION INJECTION WAS ALLEGEDLY LEAKED. REPORTEDLY, THERE IS A LITTLE HOLE IN THE LUER CONNECTION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182796 ↗
• MalfunctionMar 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY SEVEN DAYS POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY DEFLATED AND A STERILIZED WATER LEAK WAS IDENTIFIED. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818726 ↗
• InjuryMar 9, 2020Break; Break

  IT WAS REPORTED THAT APPROXIMATELY NINE DAYS POST GASTROSTOMY SURGERY THE PATIENT WAS HOSPITALIZED AND THE FEEDING DEVICE ALLEGEDLY BROKE AT THE CONNECTION SITE. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED BACTEREMIA. REPORTEDLY, A NEW FEEDING DEVICE WAS PLACED. THE PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 9807533 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST GATROSTOMY SURGERY THE FEEDING TUBE BALLOON ALLEGEDLY DEFLATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806587 ↗
• MalfunctionJan 30, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT APPROXIMATELY FOURTEEN DAYS POST FEEDING TUBE PLACEMENT, DURING THE REPLACEMENT PROCESS, THE MEDICATION INJECTION PORT WAS ALLEGEDLY LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648823 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation

  IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, THERE WAS ALLEGEDLY A HOLE IN ONE OF THE EXTERNAL COMPONENTS. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED ON THE SAME DAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516237 ↗
• MalfunctionOct 11, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT APPROXIMATELY THIRTEEN DAYS POST FEEDING DEVICE PLACEMENT, THE CUFF ALLEGEDLY RUPTURED WHICH LED TO FEEDING TUBE DISLODGEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180722 ↗
• MalfunctionOct 8, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT POST GASTROSTOMY FEEDING TUBE PLACEMENT THE DEVICE WAS FILLED WITH STERILIZED WATER AND ALLEGEDLY LEAKED. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169858 ↗
• MalfunctionJul 23, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 716 STANDARD PROFILE REPLACEMENT DEVICE ALLEGEDLY EXPERIENCED FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITHOUT CONSEQUENCE. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817256 ↗
• MalfunctionJul 17, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000716, REPLACEMENT GASTROSTOMY TUBE ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797086 ↗
• MalfunctionApr 18, 2019Deflation Problem; Deflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL 000716 FEEDING DEVICE ALLEGEDLY EXPERIENCED A DEFLATION ISSUE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED PATIENT CONTACT WITH THE DEVICE, WITH NO REPORTED PATIENT INJURY. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528613 ↗
• MalfunctionNov 19, 2018Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087293 ↗
• MalfunctionOct 3, 2018Burst Container or Vessel; Deflation Problem; Burst Container or Vessel; Deflation Problem

  IT WAS REPORTED THAT, APPROXIMATELY FIVE YEARS POST USE, THE BALLOON ALLEGEDLY RUPTURED ON A FEEDING DEVICE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURE WAS IDENTIFIED AFTER THE FEEDING CATHETER EXISTED THROUGH THE STOMA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929130 ↗
• MalfunctionJul 3, 2018Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY FELL OUT OF THE PATIENT. REPORTEDLY, THERE WAS A NARROW GAP BETWEEN THE STOMACH WALL AND THE ABDOMINAL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7659220 ↗
• MalfunctionJun 28, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATED, ALLEGEDLY DUE TO A PINHOLE OR A TEAR. REPORTEDLY THE CATHETER FELL OUT OF THE PATIENT. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648517 ↗
• MalfunctionJun 28, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT 8 DAYS AFTER PLACEMENT THE BALLOON DEFLATED, ALLEGEDLY DUE TO A PINHOLE OR A TEAR. REPORTEDLY THE CATHETER FELL OUT OF THE PATIENT. IT WAS STATED THAT PRIOR TO PLACEMENT A PRETEST HAD BEEN COMPLETED. THE DEVICE WAS REMOVED AND A NEW DEVICE PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648290 ↗
• MalfunctionJun 14, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE ALLEGEDLY OCCURRED POST PROBE INTRODUCTION. IT WAS FURTHER ALLEGED THAT THE PRODUCT USER TESTED THE BALLOON BEFORE THE PROCEDURE AND IT WAS NORMAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602592 ↗
• MalfunctionMay 18, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER PERFORMING THE BALLOON TEST, IN ATTEMPT TO INTRODUCE THE PROBE, THE BALLOON RIPPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7526680 ↗