Bard Button Replacement Gastrostomy Device 000284Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801741087872), received between Feb 28, 2017 and Aug 22, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST FEEDING DEVICE IMPLANT, THE DEVICE WAS ALLEGEDLY LEAKING PROFUSELY. 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 12352008 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST BUTTON GASTROSTOMY FEEDING TUBE USE, THE BUTTON VALVE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED AND ANOTHER BUTTON FEEDING TUBE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269133 ↗
• MalfunctionDec 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BUTTON ADAPTER ALLEGEDLY KEPT DETACHING FROM THE FEEDING TUBE AND WOULD NOT STAY CONNECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125268 ↗
• MalfunctionOct 18, 2017Leak/Splash; Sticking

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD A G-TUBE PLACED ON FRIDAY, (B)(6) 2017 TO REPLACE HER PRIOR PEG TUBE. SHE STATED THAT WHEN THE PORT FLIPS OPEN TO ATTACH THE TUBE, BILE SPILLS OUT. MEDICAL SERVICES & SUPPORT INFORMED THE PATIENT THAT THERE IS A VALVE THAT SOMETIMES BECOMES STUCK, ALLOWING STOMACH CONTENTS TO LEAK THROUGH. MS&S GAVE THE PATIENT VERBAL INSTRUCTIONS ON HOW TO USE THE DECOMPRESSION TUBE TO DECOMPRESS THE STOMACH AND ALSO TO REPLACE THE VALVE INTO THE CORRECT POSITION. PATIENT WAS ALSO ADVISED TO CONTACT PHYSICIAN.

  Patient problems: No Code Available

  MAUDE report 6959567 ↗
• MalfunctionMar 23, 2017Leak/Splash

  AS REPORTED BY THE PATIENT'S MOTHER TO MEDICAL SERVICES, PATIENT USES THE 18FR, 3.4 CM BARD BUTTON TUBE. PATIENT'S MOTHER ALLEGED LEAKAGE THROUGH THE TUBE. MEDICAL SERVICES DISCUSSED POSSIBLE CAUSES OF LEAKAGE THROUGH THE TUBE AND SUGGESTED THEY FOLLOW UP WITH PHYSICIAN. NO REPORTED HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6428402 ↗
• MalfunctionFeb 28, 2017Device Operates Differently Than Expected

  THE PATIENT¿S MOTHER REPORTED THAT A BARD BUTTON WAS INSERTED ON (B)(6) 2017, BY A GASTROENTEROLOGIST. NO IMMEDIATE ISSUES WERE NOTED AT THE TIME OF PLACEMENT. THE MOTHER STATED THAT THE PATIENT DID NOT HAVE A LARGE AMOUNT OF FLUID FLUSHED AT THE TIME OF PLACEMENT, AS THE INSERTION WAS QUITE TRAUMATIC FOR THE PATIENT. THE BUTTON WAS PLACED FOR DECOMPRESSION AND HYDRATION (NON-FEEDING). THE MOTHER REPORTED THAT THERE WAS NO LEAKAGE AROUND THE TUBE BUT AN "OVERFLOW BACK OUT OF THE ACTUAL PORT¿. THE MOTHER WAS UNABLE TO GET THE CAP ON QUICK ENOUGH TO PREVENT THE PATIENT FROM GETTING SOAKED. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6365641 ↗