Bard Tri-Funnel Replacement Gastrostomy Tube 000714Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741037122), received between Apr 18, 2017 and Feb 18, 2021 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2021Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING FEEDING DEVICE IMPLANT, THE BALLOON ALLEGEDLY INFLATED ASYMMETRICALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341698 ↗
• MalfunctionDec 17, 2020Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING FEEDING DEVICE PLACEMENT, THE BALLOON ALLEGEDLY COULD NOT BE INFLATED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11033814 ↗
• MalfunctionOct 9, 2020Fluid/Blood Leak; Leak/Splash; Material Puncture/Hole; Fluid/Blood Leak; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING PREPARATION FOR A FEEDING TUBE PLACEMENT THE CUFF OF THE DEVICE ALLEGEDLY HAD A HOLE IN IT. IT WAS FURTHER REPORTED THAT THE CUFF LEAKED AT THE TIME OF INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10659726 ↗
• MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST FEEDING TUBE PLACEMENT, THE BALLOON ALLEGEDLY DEFLATED AND A LEAK OF STERILE WATER WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823417 ↗
• MalfunctionMar 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED APPROXIMATELY SEVEN DAYS POST GASTROSTOMY FEEDING TUBE PLACEMENT, THE FEEDING TUBE BALLOON HAD ALLEGEDLY DEFLATED AND A STERILE WATER LEAKAGE WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794778 ↗
• MalfunctionJul 24, 2019Inflation Problem; Inflation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000714 FEEDING DEVICE ALLEGEDLY EXPERIENCED AN INFLATION PROBLEM. 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 8821784 ↗
• MalfunctionNov 20, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN YEARS POST USE, THE BALLOON ON THE GASTROSTOMY TUBE ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092274 ↗
• MalfunctionOct 4, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER IMMEDIATELY CAME OFF AFTER PLACEMENT. IT WAS CONFIRMED THAT STERILIZED WATER LEAKAGE WAS FOUND FROM THE BALLOON WHEN THE BALLOON WAS INFLATED AGAIN AND CHECKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936391 ↗
• MalfunctionAug 9, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT ALLEGEDLY THE FEEDING TUBE UNINTENTIONALLY DISLODGED FROM THE PATIENT. IT WAS REPORTED THAT THE BALLOON RUPTURED AND LEAKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768048 ↗
• MalfunctionJul 25, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PRODUCT CODE AND THE LOT NUMBER DO NOT MATCH THE PRODUCT DESCRIPTION. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7720112 ↗
• MalfunctionJul 23, 2018Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT SALINE LEAKAGE WAS FOUND FROM THE BALLOON. THE DEVICE WAS REPLACED AFTER THE ALLEGED EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712827 ↗
• MalfunctionJun 28, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PLACEMENT PROCEDURE, THE BALLOON WAS ALLEGEDLY INFLATED ASYMMETRICALLY, SO THE TUBE WAS UNABLE TO BE IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 7648603 ↗
• MalfunctionJun 14, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND NINE DAYS AFTER USE, THE BALLOON ON THE FEEDING TUBE ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER FEEDING TUBE WAS PLACED AT A LATER DATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602929 ↗
• MalfunctionJun 14, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A BALLOON ALLEGEDLY RUPTURED APPROXIMATELY TWENTY DAYS POST USE AND THE DEVICE WAS REPLACED. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602788 ↗
• MalfunctionJun 5, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT 16 DAYS AFTER PLACEMENT THE BALLOON RUPTURED.

  Patient problems: Hypoglycemia

  MAUDE report 7571940 ↗
• MalfunctionMay 23, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON COMPONENT OF A FEEDING CATHETER ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539343 ↗
• MalfunctionSep 28, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE DEVICE WAS COMING OFF THE PATIENT AS THE BALLOON WAS DEFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901868 ↗
• MalfunctionSep 7, 2017Inflation Problem

  IT WAS REPORTED THAT DURING THE PRETEST, ALLEGEDLY THE BALLOON WOULD ONLY INFLATE ON ONE SIDE. DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6850043 ↗
• MalfunctionAug 24, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURES WERE OBSERVED CONSECUTIVELY 8 TIMES ON THE SAME PATIENT DURING ABOUT 3 WEEKS. THIS REPORT DESCRIBES THE 4TH BALLOON RUPTURE. THE 14FR TUBE WAS INSERTED ON (B)(6) 2016 AND FOUND TO BE REMOVED SPONTANEOUSLY FROM THE PATIENT AND RUPTURED ON (B)(6) 2016. THE DEVICE WAS USED FOR THE ADMINISTRATION OF THE ANTICONVULSANT TO THE PATIENT. THE MEDICINES ADMINISTRATED WERE AS FOLLOWS: SODIUM VALPRORATE 20%, ZONISAMIDE 100 MG, PROSESIYA TABLET 20 MG, ASPARA POTASSIUM ACID 50%, MAGMITT 330 MG. (TABLETS WERE CRUSHED WHEN IT ADMINISTERED.)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816396 ↗
• MalfunctionAug 24, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURES WERE OBSERVED CONSECUTIVELY 8 TIMES ON THE SAME PATIENT DURING ABOUT 3 WEEKS. THIS REPORT DESCRIBES THE 3RD BALLOON RUPTURE. THE 14FR TUBE WAS INSERTED ON (B)(6) 2016 AND FOUND TO BE REMOVED SPONTANEOUSLY FROM THE PATIENT AND RUPTURED ON (B)(6) 2016. THE DEVICE WAS USED FOR THE ADMINISTRATION OF THE ANTICONVULSANT TO THE PATIENT. THE MEDICINES ADMINISTRATED WERE AS FOLLOWS: SODIUM VALPRORATE 20%, ZONISAMIDE 100 MG, PROSESIYA TABLET 20 MG, ASPARA POTASSIUM ACID 50%, MAGMITT 330 MG. (TABLETS WERE CRUSHED WHEN IT ADMINISTERED.)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6816349 ↗
• MalfunctionAug 22, 2017Inflation Problem

  IT WAS REPORTED THAT BEFORE DOING AN INFLATION TEST OF THE DEVICE AND BEFORE INSERTING IT INTO THE PATIENT, THE OPERATOR COULD NOT INFLATE IT COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811100 ↗
• MalfunctionAug 18, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURES WERE OBSERVED CONSECUTIVELY 8 TIMES ON THE SAME PATIENT DURING ABOUT 3 WEEKS. THIS REPORT DESCRIBES THE 2ND BALLOON RUPTURE. THE 14FR TUBE WAS INSERTED ON (B)(6) 2016 AND FOUND TO BE REMOVED SPONTANEOUSLY FROM THE PATIENT AND RUPTURED ON (B)(6) 2016. THE DEVICE WAS USED FOR THE ADMINISTRATION OF THE ANTICONVULSANT TO THE PATIENT. THE MEDICINES ADMINISTRATED WERE AS FOLLOWS: SODIUM VALPRORATE 20%, ZONISAMIDE 100 MG, PROSESIYA TABLET 20 MG, ASPARA POTASSIUM ACID 50%, MAGMITT 330 MG. (TABLETS WERE CRUSHED WHEN IT ADMINISTERED.)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806099 ↗
• MalfunctionJun 6, 2017Break

  IT WAS REPORTED THAT THE DEVICE WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017 DUE TO THE CUFF ON THE DEVICE BREAKING. NO OTHER INFORMATION WAS PROVIDED. NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6616779 ↗
• MalfunctionJun 6, 2017Break

  IT WAS REPORTED THAT THE DEVICE WAS PLACED IN (B)(6) 2016 AND WITHDRAWN ON (B)(6) 2017. CAREGIVER REPORTS THAT CUFF WAS INFLATED WITH 4-5 ML OF DISTILLED WATER. USE OF HOMEMADE DIET WAS CRUSHED AND SIFTED. AFTER THAT, THE DEVICE WAS CLEANED WITH WATER. CLIENT INFORMED THAT THE PATIENT PRESENTED SOME CHARACTERISTICS/SYMPTOMS THAT THE BALLOON HAD BROKEN. IT WAS FOUND THAT THE CUFF ON THE DEVICE WAS BROKEN. THE DEVICE WAS REMOVED AND REPLACED. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616724 ↗
• MalfunctionMay 24, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS IN USE OF THE PROBE SINCE (B)(6) 2017. ON (B)(6) 2017, THE PROBE LEFT THE STOMA. UPON OBSERVING THE PRODUCT, THE TEAM DETECTED CUFF/BALLOON DISRUPTION. WATER WAS USED TO INFLATE THE BALLOON AFTER PLACING THE PATIENT TO THE VOLUME INDICATED IN THE PRODUCT INSTRUCTIONS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6589149 ↗