Bard Button Replacement Gastrostomy Device 000286Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10801741087896), received between Jul 27, 2017 and Jun 14, 2022 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683254 ↗
• MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683252 ↗
• MalfunctionJun 14, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE POPS ALLEGEDLY OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A LEAK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14683064 ↗
• MalfunctionJan 19, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, FOOD ALLEGEDLY WOULD NOT GO THROUGH THE FEEDING TUBE AND INTO THE BUTTON. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13287653 ↗
• InjuryAug 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY HAD AN INFLAMMATION AND INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12313030 ↗
• InjuryMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST REPLACEMENT OF THE TUBE, THE DEVICE ALLEGEDLY LEAKED AROUND THE BUTTON. IT WAS FURTHER REPORTED THAT THE PATIENT HAD INFLAMMATION OF THE ABDOMEN AND INFECTION. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11420453 ↗
• MalfunctionJan 14, 2020Leak/Splash; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000286 FEEDING TUBE ALLEGEDLY EXPERIENCED LEAK / SPLASH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OLD, FEMALE; HOWEVER, WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587239 ↗
• MalfunctionSep 21, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER SOME DAYS (TIME UNKNOWN) OF A FEEDING DEVICE BUTTON INSTALLMENT, THERE WAS AN ALLEGED LEAK BETWEEN THE BUTTON AND THE EXTENSIONS. IT WAS FURTHER REPORTED THAT THE EXTENSIONS ALLEGEDLY LEAKED FOR APPROXIMATELY FOUR DAYS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898853 ↗
• InjuryNov 22, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT'S BUTTON WAS PLACED ON (B)(6) 2017. THE BUTTON WAS PLACED WITHOUT INCIDENT UNTIL THIS PAST WEEK WHEN IT STARTED LEAKING STOMACH ACIDS. THE BUTTON WAS REMOVED AND A NEW BUTTON PLACED (B)(6) 2017. PATIENTS STOMACH IS BURNED AND IS BEING TREATED WITH SILVADENE.

  Patient problems: Burn(s)

  MAUDE report 7054027 ↗
• MalfunctionNov 17, 2017Fluid/Blood Leak

  THE DEVICE WAS INSERTED IN THE PATIENT ON (B)(6) 2017 AND THE LEAKAGE WAS FOUND WHEN THE PATIENT WENT HOME. THE PATIENT CAME TO THE HOSPITAL FOR REPLACEMENT OF THE DEVICE ON (B)(6) 2017. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7043066 ↗
• MalfunctionOct 5, 2017Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER DAUGHTER'S BUTTON BEGAN LEAKING DUE TO AN ALLEGED VALVE BREAKDOWN AND LEAKED OF STOMACH ACIDS. THIS BUTTON WAS ORIGINALLY PLACED ON (B)(6) 2017 AND HAD TO BE REMOVED TODAY (B)(6) 2017. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918989 ↗
• MalfunctionJul 27, 2017Fluid/Blood Leak

  THE PATIENTS MOTHER REPORTED THAT THE TUBING/BUTTON THAT WAS PLACED IN (B)(6) 2017, LASTED LESS THAN ONE MONTH AND BEGAN LEAKING. THE MOTHER STATED THAT IF SHE USES THE "OLD" TUBING SHE HAS HAD AT HOME THE BUTTON DOES NOT LEAK. WHEN USING THE "NEW" TUBING IT APPEARS THE LEAK IS COMING FROM THE TUBE AND NOT THE BUTTON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747330 ↗
• InjuryJul 27, 2017Leak/Splash

  THE PATIENTS MOTHER REPORTED THAT THE TUBING/BUTTON THAT WAS PLACED IN (B)(6) 2017, LASTED LESS THAN ONE MONTH AND BEGAN LEAKING. THE PATIENT HAS HAD BURNS ON HER STOMACH FROM THE ACID THAT IS LEAKING FROM THE TUBING/BUTTON. THE BURN HAS HEALED AND THE PATIENT IS DOING FINE. THE MOTHER ALLEGES THAT THE BUTTON MAY BE OKAY AND THE LEAK IS FROM THE "NEW" TUBING.

  Patient problems: Burn(s)

  MAUDE report 6746702 ↗