Bard Tri-Funnel Replacement Gastrostomy Tube 000712Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741037115), received between Apr 19, 2017 and Mar 11, 2021 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BALLOON ALLEGEDLY HAD LEAK. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464221 ↗
• InjuryOct 20, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT ONE DAY POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE FEEDING TUBE WAS ALLEGEDLY FRACTURED AND EDEMA WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Swelling/ Edema

  MAUDE report 10703531 ↗
• MalfunctionSep 22, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY HAD OBSTRUCTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566431 ↗
• InjuryMar 25, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY INFLATED ASYMMETRICALLY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY NOT PROPERLY NOURISHED . REPORTEDLY, THE DEVICE WAS REPLACED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Injury

  MAUDE report 9880370 ↗
• InjuryMar 25, 2020Break; Break

  IT WAS REPORTED THAT SOME TIME POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE TUBE ALLEGEDLY FISSURED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY NOT PROPERLY NOURISHED. REPORTEDLY, THE DEVICE WAS REPLACED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Injury

  MAUDE report 9878737 ↗
• MalfunctionOct 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INFLATION THE FEEDING DEVICE BALLOON ALLEGEDLY LEAKED STERILIZED WATER FROM THE SHAFT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9216415 ↗
• MalfunctionJan 15, 2019Break; Break

  IT WAS REPORTED THAT THERE WAS AN ALLEGED LEAK AT THE PROBE THROUGH THE FEEDING TUBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248518 ↗
• MalfunctionAug 1, 2018Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL ATTEMPTED TO INJECT STERILIZED WATER INTO THE BALLOON AND THE BALLOON DID NOT INFLATE DUE TO ALLEGED CRACKS IN THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741282 ↗
• MalfunctionOct 5, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT ONE DAY AFTER THE PROBE INSTALLATION, IT PRESENTED A LEAK. THE CUFF WAS TESTED BEFORE USE WITH 3 ML OF DISTILLED WATER. IT WAS NECESSARY TO CHANGE THE PRODUCT. THE PATIENT WAS ALREADY USING THE PROBE PREVIOUSLY. THE PROBE WAS PASSED IN AN OUTPATIENT PROCEDURE, WITH USE OF NAN DIET (INFANT FORMULA). THIS FILE ADDRESSES SAMPLE #1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919346 ↗
• MalfunctionOct 5, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT ONE DAY AFTER THE PROBE INSTALLATION, IT PRESENTED A LEAK. THE CUFF WAS TESTED BEFORE USE WITH 3 ML OF DISTILLED WATER. IT WAS NECESSARY TO CHANGE THE PRODUCT. THE PATIENT WAS ALREADY USING THE PROBE PREVIOUSLY. THE PROBE WAS PASSED IN AN OUTPATIENT PROCEDURE, WITH USE OF NAN DIET (INFANT FORMULA). THIS FILE ADDRESSES SAMPLE #2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919141 ↗
• MalfunctionApr 19, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED.

  Patient problems: No Information

  MAUDE report 6504552 ↗