Bard Tri-Funnel Replacement Gastrostomy Tube 000724Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741037177), received between Jun 2, 2017 and Aug 22, 2022 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (26 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE BALLOON WAS ALLEGEDLY BROKEN AT THE MOMENT OF INFLATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264016 ↗
• MalfunctionOct 10, 2021Degraded; Fluid/Blood Leak; Migration; Degraded; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST TUBE PLACEMENT, THE TUBE ALLEGEDLY BUSTED AND COMPLETELY DESTROYED AND WHAT LITTLE WAS LEFT WAS BLACK IN COLOR. IT WAS FURTHER REPORTED THAT ACID LEAKING AROUND THE BALLOON. REPORTEDLY, THE BALLOON SLIDES IN AND OUT FREELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Skin Inflammation/ Irritation

  MAUDE report 12602653 ↗
• InjuryOct 10, 2021Burst Container or Vessel; Degraded; Material Discolored; Fluid/Blood Leak; Migration; Burst Container or Vessel; Degraded; Material Discolored; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST FEEDING TUBE PLACEMENT, THE TUBE ALLEGEDLY HAD A BURST AND COMPLETELY DESTROYED AND WHAT LITTLE WAS LEFT WAS BLACK IN COLOR. IT WAS FURTHER REPORTED THAT ACID WAS ALLEGEDLY LEAKING AROUND THE BALLOON AND IRRITATING THE TRACT WITH PAIN. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 12602652 ↗
• InjuryJun 4, 2021Degraded; Fluid/Blood Leak; Deformation Due to Compressive Stress; Migration; Degraded; Fluid/Blood Leak; Deformation Due to Compressive Stress; Migration

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON ALLEGEDLY DISINTEGRATE DUE TO STOMACH ACID AND ACID LEAKING AROUND THE TUBING. IT WAS FURTHER REPORTED THAT THE TIME BETWEEN TUBE CHANGES HAS CONTINUALLY SHORTENED IN THE LAST 5 YEARS OR SO. NOW, THEY MIGHT LAST 2-3 MONTHS. REPORTEDLY PATIENT EXPERIENCING PAIN AROUND THE SITE. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Pain

  MAUDE report 11937078 ↗
• MalfunctionJan 13, 2021Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO DAYS POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON ALLEGEDLY INFLATED ASYMMETRICALLY AND NUTRITION LEAKED OUT FROM FISTULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162361 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE TUBE LEAKING OUT THE TOP AND FROM AROUND THE STOMA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873242 ↗
• MalfunctionNov 20, 2020Break; Fluid/Blood Leak; Migration; Break; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT APPROXIMATELY THIRTY-FIVE DAYS POST GASTROSTOMY TUBE PLACEMENT, THE TUBE ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. IT WAS REVEALED THAT THE BALLOON RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873166 ↗
• MalfunctionAug 28, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO FEEDING TUBE PLACEMENT, FOREIGN MATERIAL WAS ALLEGEDLY FOUND IN THE PORT KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10464921 ↗
• MalfunctionAug 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY SEVEN DAYS POST GASTROSTOMY FEEDING TUBE PLACEMENT, A STERILE WATER LEAKAGE WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10361454 ↗
• MalfunctionJul 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY TWENTY SIX 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 10306884 ↗
• MalfunctionJul 16, 2020Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE GASTROSTOMY TUBE OF THE PATIENT WAS REPLACED DUE TO THE RUPTURE OF THE BALLOON. WHEN CARRYING OUT THE TEST TO CHECK THE INTEGRITY OF THE BALLOON, IN THE RESERVE PROBE, IT WAS FOUND THAT IT WAS DEFECTIVE, SO A SECOND RESERVE PROBE WAS USED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10282421 ↗
• MalfunctionJul 7, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST GASTROSTOMY TUBE PLACEMENT, A STERILIZED WATER LEAK FROM THE BALLOON WAS IDENTIFIED AND THE BALLOON HAD ALLEGEDLY DEFLATED. IT WAS FURTHER REPORTED THAT, THE TUBE CAME OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238123 ↗
• MalfunctionJul 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND TWO WEEKS 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 10222669 ↗
• MalfunctionJun 30, 2020Difficult to Insert; Difficult to Open or Close; Difficult to Insert; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE FEEDING INSERT PROCEDURE, THE DEVICE WAS ALLEGEDLY FAILED TO INSERT DUE TO THE PROXIMAL EDGE WAS FLANGED THAT IS PREVENTING THE PEG TUBE ENTERING. THE PROCEDURE WAS COMPLETED WITH USING ANTHER BRAND DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10210902 ↗
• MalfunctionJun 30, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON RUPTURE WAS FOUND WHEN REPLACING STERILIZED WATER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10210616 ↗
• MalfunctionJun 15, 2020Break; Break

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST FEEDING TUBE PLACEMENT, THE TUBE ALLEGEDLY TORE.THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152922 ↗
• MalfunctionMay 20, 2020Break; Fluid/Blood Leak; Device Dislodged or Dislocated; Break; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER FOUR WEEKS OF GASTROSTOMY TUBE PLACEMENT, THE BALLOON OF THE TUBE ALLEGEDLY RUPTURED WITH STERILIZED WATER LEAK AND LEADS TO A DISLODGEMENT. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075643 ↗
• MalfunctionMay 20, 2020Break; Fluid/Blood Leak; Device Dislodged or Dislocated; Break; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER FOUR WEEKS OF GASTROSTOMY TUBE PLACEMENT, THE BALLOON OF THE TUBE ALLEGEDLY RUPTURED WITH STERILIZED WATER LEAK AND LEADS TO A DISLODGEMENT. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075399 ↗
• MalfunctionMay 20, 2020Break; Fluid/Blood Leak; Device Dislodged or Dislocated; Break; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON OF THE TUBE ALLEGEDLY RUPTURED WITH STERILIZED WATER LEAK AND LEADS TO A DISLODGEMENT. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075182 ↗
• MalfunctionMay 19, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIBERS WERE ALLEGEDLY FOUND ON THE END OF THE TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10073172 ↗
• MalfunctionMay 19, 2020Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON OF THE TUBE ALLEGEDLY RUPTURED WITH STERILIZED WATER LEAK AND LEADS TO A DISLODGEMENT. REPORTEDLY, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10071340 ↗
• MalfunctionMay 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TESTING OF A FEEDING DEVICE PRIOR TO PATIENT USE, THE BALLOON ALLEGEDLY LEAKED SALINE FLUID. REPORTEDLY, THE DEVICE WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY PERFORMED WITH ANOTHER DEVICE OF THE SAME KIND. THERE A NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10040853 ↗
• MalfunctionApr 28, 2020Break; Fluid/Blood Leak; Device Dislodged or Dislocated; Break; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT TWO MONTHS POST G-TUBE PLACEMENT, THE BALLOON ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE G-TUBE WAS REQUIRED TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007835 ↗
• MalfunctionApr 27, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT THE DOCTOR TESTED THE BALLOON ON THE TRI-FUNNEL REPLACEMENT GASTROSTOMY TUBE, BEFORE USE. THE DEVICE LEAKED SALINE DURING THE TEST, THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER PRODUCT FROM THE SAME LOT NUMBER.

  Patient problems: No Patient Involvement

  MAUDE report 10001911 ↗
• MalfunctionMar 25, 2020Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST GASTROSTOMY TUBE PLACEMENT, THE BALLOON OF THE TUBE ALLEGEDLY RUPTURED AND LEAD TO DISLODGEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881023 ↗