Bard Tri-Funnel Replacement Gastrostomy Tube 000720Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00801741037153), received between Mar 23, 2016 and Dec 7, 2021 — classified as 1 death, 4 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (49 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 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2021Fluid/Blood Leak; Fracture; Inflation Problem; Fluid/Blood Leak; Fracture; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE WAS PREPPED BY INFUSING WATER INTO THE BALLOON TRACK AND THE WATER ALLEGEDLY LEAKED THROUGH THE END HOLE AND THE DEVICE DID NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958253 ↗
• MalfunctionDec 7, 2021Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT PRIOR TO A GASTROSTOMY FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE WAS PREPPED BY INFUSING WATER INTO THE BALLOON TRACK AND THE WATER ALLEGEDLY LEAKED THROUGH THE END HOLE AND THE DEVICE DID NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958252 ↗
• InjurySep 29, 2021Fracture; Device Dislodged or Dislocated; Migration; Fracture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. THE PATIENT WAS REPORTEDLY STABILIZED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12548466 ↗
• MalfunctionSep 9, 2021Fracture; Device Dislodged or Dislocated; Migration; Fracture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE CATHETER ALLEGEDLY DISLODGED AND FELL OUT OF THE PATIENT. THE PATIENT WAS REPORTEDLY STABILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446789 ↗
• MalfunctionJul 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST PORT PLACEMENT, THE CAP WAS ALLEGEDLY TEARED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236947 ↗
• MalfunctionJul 23, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT AFTER PLACING THE GASTROSTOMY TUBE, IT WAS NOTICED THAT THERE WAS NO PRINTING ON THE GASTROSTOMY TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215781 ↗
• MalfunctionJul 5, 2021Disconnection; Material Split, Cut or Torn; Disconnection; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST FEEDING DEVICE PLACEMENT, THE DEVICE ALLEGEDLY TORN. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY CAME OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114743 ↗
• MalfunctionJul 5, 2021Migration; Material Split, Cut or Torn; Migration; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST FEEDING DEVICE PLACEMENT, THE DEVICE ALLEGEDLY EXTERIORIZED. IT WAS FURTHER REPORTED THAT THE CUFF WAS FOUND TO BE TORN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114741 ↗
• MalfunctionJul 5, 2021Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE FEEDING DEVICE PLACEMENT PROCEDURE, THE CUFF WAS TORN AND THERE IS A OBSTRUCTION OF FLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12114701 ↗
• MalfunctionFeb 10, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY FEEDING TUBE PLACEMENT, A STERILE WATER WAS ALLEGEDLY LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306139 ↗
• MalfunctionJan 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11191882 ↗
• MalfunctionJan 19, 2021Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11191881 ↗
• MalfunctionDec 14, 2020Device Dislodged or Dislocated; Material Deformation; Migration; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Deformation; Migration; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY SHRANK. IT WAS FURTHER REPORTED THAT CATHETER WAS DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001909 ↗
• MalfunctionNov 4, 2020Material Rupture; Device Dislodged or Dislocated; Migration; Material Rupture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT APPROXIMATELY 17 DAYS POST FEEDING TUBE PLACEMENT, THE CATHETER ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10784449 ↗
• MalfunctionNov 4, 2020Material Rupture; Device Dislodged or Dislocated; Migration; Material Rupture; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT APPROXIMATELY 15 DAYS POST FEEDING TUBE PLACEMENT, THE CATHETER ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10784384 ↗
• MalfunctionNov 2, 2020Deflation Problem; Improper or Incorrect Procedure or Method; Migration; Deflation Problem; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON WAS SLOWLY DEFLATE AND THE TUBE WAS NOT IN PLACE SO THE TUBE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10768638 ↗
• MalfunctionOct 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AND TWO WEEKS POST GASTROSTOMY TUBE PLACEMENT, THE GASTROSTOMY TUBE WAS ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10725631 ↗
• MalfunctionOct 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH OF GASTROSTOMY TUBE PLACEMENT , THE DEVICE ALLEGEDLY RUPTURED AND LEAKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10687325 ↗
• MalfunctionOct 12, 2020Fluid/Blood Leak; Fracture; Expulsion; Fluid/Blood Leak; Fracture; Expulsion

  IT WAS REPORTED THAT THE BALLOON OF THE GASTROSTOMY TUBE ALLEGEDLY RUPTURED APPROXIMATELY ONE MONTH AND TWENTY THREE DAYS POST PLACEMENT. REPORTEDLY IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10666952 ↗
• MalfunctionSep 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476310 ↗
• MalfunctionSep 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SOMETIME POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476210 ↗
• MalfunctionSep 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST GASTROSTOMY TUBE PLACEMENT, THE FEEDING TUBE BALLOON ALLEGEDLY RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476208 ↗
• MalfunctionAug 12, 2020Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  IT WAS REPORTED THAT POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY EXPERIENCED RECURRENT TUBE LEAKAGE. IT WAS FURTHER REPORTED THAT APPROXIMATELY FOUR MONTHS POST FEEDING TUBE PLACEMENT DURING EXAMINATION, BALLOON WAS ALLEGEDLY FOUND TO BE DEFLATED AND THE FEEDING DEVICE COULD BE REMOVED EASILY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394781 ↗
• MalfunctionAug 10, 2020Fluid/Blood Leak; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn; Fluid/Blood Leak; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT APPROXIMATELY SEVEN DAYS POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY SHRANK. IT WAS FURTHER REPORTED THAT THE CATHETER DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383489 ↗
• MalfunctionAug 10, 2020Fluid/Blood Leak; Device Dislodged or Dislocated; Material Deformation; Fluid/Blood Leak; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SEVEN DAYS POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY SHRANK. IT WAS FURTHER REPORTED THAT THE CATHETER DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383458 ↗