Bard Tri-Funnel Replacement Gastrostomy Tube 000722Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741037160), received between Apr 28, 2017 and Jul 28, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2021Disconnection; Fracture; Device Dislodged or Dislocated; Disconnection; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SOMETIMES POST FEEDING DEVICE PLACEMENT, THE PROBE ALLEGEDLY DISLODGED. IT WAS FURTHER REPORTED THAT THE CUFF ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236909 ↗
• MalfunctionJul 2, 2021Partial Blockage; Difficult to Flush; Fracture; Failure to Infuse; Obstruction of Flow; Partial Blockage; Difficult to Flush; Fracture; Failure to Infuse; Obstruction of Flow

  IT WAS REPORTED THAT PRIOR TO FEEDING TUBE PLACEMENT, THE DEVICE ALLEGEDLY UNABLE TO INFUSE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106911 ↗
• MalfunctionMay 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO THE PLACEMENT OF FEEDING TUBE, THE DEVICE ALLEGEDLY LEAKED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824555 ↗
• MalfunctionNov 11, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT FOUR DAYS POST PORT PLACEMENT, A LEAKAGE WAS NOTED AT THE SECOND LUMEN CONNECTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10821044 ↗
• MalfunctionSep 28, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON SPLIT DOWN THE SIDE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919753 ↗
• MalfunctionSep 28, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON SPLIT DOWN THE SIDE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919529 ↗
• MalfunctionSep 28, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON SPLIT DOWN THE SIDE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919435 ↗
• MalfunctionSep 28, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON SPLIT DOWN THE SIDE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919323 ↗
• MalfunctionSep 28, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON HAD PIN HOLES IN IT. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918621 ↗
• MalfunctionSep 27, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE PATIENT¿S FEEDING BALLOON HAD PIN HOLES IN IT. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914454 ↗
• MalfunctionAug 9, 2018Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON IS NOT SYMMETRICAL, ONLY COVERING HALF OF THE TUBE, AND THERE IS A LEAK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770326 ↗
• MalfunctionMay 7, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE VALVE OF THE BALLOON WAS NOT WORKING, AFTER PLACEMENT AND INFLATION LIQUID LEAKED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7492898 ↗
• MalfunctionApr 4, 2018Hole In Material

  IT WAS REPORTED THAT A HOLE WAS FOUND ON THE BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7395664 ↗
• MalfunctionFeb 13, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE COLOR SLIDES ON THE PROBE DAMAGES THE SKIN OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 7267953 ↗
• MalfunctionMay 18, 2017Device Operates Differently Than Expected

  AS REPORTED BY THE FACILITY TO MS&S, "CALLER STATES A PATIENT WITH PRODUCT 000722, 22FR TRI-FUNNEL GASTROSTOMY TUBE IS HAVING ISSUES WITH THE TUBE POPPING OPEN. CALLER PROVIDED LOT NUMBER NGAZ0963. RESPONSE EXPLAINED THAT ONE POSSIBLE REASON FOR THE TUBE POPPING OPEN CAN BE BECAUSE OF GAS PRESSURE BUILDING UP IN THE PATIENT'S STOMACH. DISCUSSED OCCASIONALLY OPENING THE CAP TO ALLOW GAS TO ESCAPE. CALLER STATES SHE MAY HAVE THE DOCTOR ORDER SOME PREVACID."

  Patient problems: Flatus

  MAUDE report 6577211 ↗
• MalfunctionApr 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TUBE FELL OFF AFTER THE PATIENT COMPLAINED OF DISCOMFORT. THE TUBE WAS PLACED FOR 1.5MONTHS. THE PATIENT DID NOT PULL THE DEVICE BY HIM/HERSELF.

  Patient problems: Discomfort

  MAUDE report 6530120 ↗