Bard Button Replacement Gastrostomy Device 000282Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10801741087858), received between Jan 6, 2016 and Nov 1, 2021 — classified as 2 injuries, 23 malfunctions.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2021Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT POST FEEDING DEVICE PLACEMENT, THE DEVICE ALLEGEDLY LEAKED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD A FITTING PROBLEM. PATIENT ALSO EXPERIENCED RASH AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Rash

  MAUDE report 12726218 ↗
• MalfunctionNov 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE DURING THE PROCEDURE, FLAP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726215 ↗
• MalfunctionOct 28, 2021Fracture; Fitting Problem; Fracture; Fitting Problem

  IT WAS REPORTED THAT THE DURING A GASTROSTOMY FEEDING TUBE PLACEMENT, THE BUTTON ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD A FITTING PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712322 ↗
• MalfunctionJun 9, 2021Fluid/Blood Leak; Reflux within Device; Fluid/Blood Leak; Reflux within Device

  IT WAS REPORTED DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY FLUID LEAK. IT WAS FURTHER REPORTED THE DEVICE ALLEGEDLY HAD REFLUX WITHIN DEVICE. IT WAS FURTHER REPORTED ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963945 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT DURING A GASTROSTOMY TUBE PLACEMENT PROCEDURE, THE LID OF THE DEVICE ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840407 ↗
• MalfunctionJul 16, 2020Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 000282 FEEDING AND DECOMPRESSION TUBES ALLEGEDLY EXPERIENCED FLUID LEAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10284316 ↗
• MalfunctionApr 19, 2019Leak/Splash; Leak/Splash

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 000282 GASTROSTOMY TUBE EXPERIENCED A LEAK. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531958 ↗
• MalfunctionSep 24, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PLACEMENT PROCEDURE THE BUTTON ALLEGEDLY LEAKED. A NEW BUTTON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7903787 ↗
• MalfunctionAug 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CAP BROKE AFTER APPROXIMATELY SIX MONTHS OF USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806471 ↗
• MalfunctionAug 14, 2018Defective Component; Defective Component

  IT WAS REPORTED THAT THE VALVE BROKE AFTER APPROXIMATELY FOUR MONTHS OF USE. THE DEVICE WAS REMOVED AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7782340 ↗
• InjuryJul 18, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CAP BROKE OFF THE GASTROSTOMY DEVICE AND THERE WAS ALSO LEAKING AT THE VALVE. THE DEVICE WAS LEAKING SO BAD AND SINCE THE CAP WAS GONE, THE PATIENT'S MOTHER USED GAUZE TO STOP THE LEAK. THE PATIENT DEVELOPED A SEVERE RASH AROUND THE SITE AND WAS PRESCRIBED BOTH ANTIBIOTIC AND STEROID CREAMS. THE SORE IS NO LONGER OPEN, BUT IT IS STILL RED, HOWEVER THE REDNESS IS FADING SLOWLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Rash

  MAUDE report 7701275 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CAP BROKE OFF THE GASTROSTOMY DEVICE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7701271 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Leak/Splash

  IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HIS BUTTON CAP CAME OFF HIS FEEDING TUBE. SHE STATED THAT THE NURSE WAS THERE AND HER SON WAS ON THE MAT, THE NURSE CLOSED THE BUTTON, BUT IT WAS STILL OPEN AND THE TIP WAS STILL IN THE HOLE. THE PATIENT'S MOTHER STATES THAT IT OPENS ALL THE TIME BY ITSELF AND FOOD COMES OUT. THE PATIENT'S MOTHER ALSO STATED THAT WHEN IT WAS INSERTED IT LOOKS LIKE IT WAS STRETCHED OUT AND IT IS "SO THIN" AND IT IS VERY UNCOMFORTABLE FOR HER SON. THE DEVICE WAS REMOVED AND WAS REPLACED WITH ANOTHER MANUFACTURERS DEVICE.

  Patient problems: Discomfort

  MAUDE report 7360187 ↗
• MalfunctionJan 15, 2018Detachment Of Device Component

  IT WAS REPORTED BY MS&S THAT THE PATIENT'S MOTHER CALLED AND INQUIRED ABOUT THE ENFIT CONNECTOR FOR HER SON'S FEEDING DEVICE. SHE STATED TO MS&S THAT EVERY FEW MONTHS THE CAP COMES OFF AND THE ENTIRE BUTTON TUBE HAS TO BE REPLACED WHEN THE CAP COMES OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191912 ↗
• MalfunctionNov 29, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT THE DOME MIGRATED. THE PATIENTS PARENTS WERE CARING FOR THE DEVICE AFTER DISCHARGE. THE DEVICE WAS INTACT BUT HAD MIGRATED OUT OF THE PATIENT'S STOMACH. THIS WAS DISCOVERED DUE TO THE CHILD COMPLAINING OF PAIN, THE PRESENCE OF SWELLING AND REDNESS AT THE INSERTION SITE, AND THE DEVICE WAS NO LONGER SITTING FLUSH AGAINST THE SKIN; THE SHAFT OF THE DEVICE WAS VISIBLE AND USUALLY ON AN ANGLE THERE IS AN OBVIOUS LUMP AT THE SITE. THERE WAS NO COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Skin Discoloration; Swelling

  MAUDE report 7069159 ↗
• MalfunctionNov 29, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT THE DOME MIGRATED. THE PATIENTS PARENTS WERE CARING FOR THE DEVICE AFTER DISCHARGE. THE DEVICE WAS INTACT BUT HAD MIGRATED OUT OF THE PATIENT'S STOMACH. THIS WAS DISCOVERED DUE TO THE CHILD COMPLAINING OF PAIN, THE PRESENCE OF SWELLING AND REDNESS AT THE INSERTION SITE, AND THE DEVICE WAS NO LONGER SITTING FLUSH AGAINST THE SKIN; THE SHAFT OF THE DEVICE WAS VISIBLE AND USUALLY ON AN ANGLE THERE IS AN OBVIOUS LUMP AT THE SITE. THERE WAS NO COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Pain; Swelling

  MAUDE report 7069098 ↗
• MalfunctionNov 29, 2017Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2017 THAT THE DOME MIGRATED. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED. THERE WAS NO REPORTED PATIENT INJURY. ON (B)(6) 2017 - PER THE REPORTING FACILITY, THE CHILD'S PARENTS WERE CARING FOR THE DEVICE ON DISCHARGE HOME AFTER RECEIVING EDUCATION FROM THE FACILITY'S TEAM. THE DEVICE WAS INTACT BUT HAD MIGRATED OUT OF THE PATIENT'S STOMACH. THIS WAS DISCOVERED DUE TO THE CHILD COMPLAINING OF PAIN, THE PRESENCE OF SWELLING AND REDNESS AT THE INSERTION SITE, AND THE DEVICE WAS NO LONGER SITTING FLUSH AGAINST THE SKIN; THE SHAFT OF THE DEVICE WAS VISIBLE AND USUALLY ON AN ANGLE THERE IS AN OBVIOUS LUMP AT THE SITE. THERE WAS NO COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Skin Discoloration; Swelling

  MAUDE report 7068530 ↗
• MalfunctionSep 14, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A COMPLAINT OF A LEAK FROM THE BUTTON FEEDING HOLE. IT WAS STATED THAT THE STOPPER MAY BE TOO SMALL FOR THE BUTTON FEEDING HOLE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865473 ↗
• MalfunctionJun 9, 2017Fluid/Blood Leak; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE BUTTON FEEDING HOLE WAS LEAKING. THE USER SUSPECTS THAT THE STOPPER IS EITHER TOO SMALL FOR THE BUTTON FEEDING HOLE OR DUE TO OTHER REASONS. IT WAS STATED THAT THE DEVICE IS STILL IN THE PATIENT DUE TO AVOID TRAUMA CAUSED BY EXPLANTING IT.

  Patient problems: No Information

  MAUDE report 6632422 ↗
• MalfunctionApr 20, 2017Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT IN (B)(6) 2017, A BARD BUTTON WAS INSERTED IN THE PATIENT TO CHANGE HIS/HER EXISTING GASTRONOMY FEEDING TUBE. THE DAY AFTER THE INSERTION, THE PATIENT RETURNED DUE TO AN ALLEGED LEAK FROM THE CENTRAL HOLE. REPORTEDLY THE LEAK WAS OBSERVED FROM THE CENTRAL HOLE POST FEEDING OF MILK. IT WAS REPORTED THAT THE STOPPER DID NOT FIT PROPERLY. NO REPORTED HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6508348 ↗
• MalfunctionMar 9, 2017Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD THE 18FR, 1.7 CM TUBE- LOW PROFILE GASTRONOMY BUTTON. THE PATIENT¿S MOTHER NOTED LEAKING THROUGH THE ¿SKIN HOLE¿, BUT THEN NOTED THE LEAK OCCURRED THROUGH THE ¿LID¿, EVEN WHEN CLOSED. THIS WAS THE INITIAL BUTTON EXCHANGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393354 ↗
• MalfunctionMar 9, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD THE 18FR, 1.7 CM TUBE- LOW PROFILE GASTRONOMY BUTTON. THE PATIENT¿S MOTHER NOTED LEAKING THROUGH THE ¿SKIN HOLE¿, BUT THEN NOTED THE LEAK OCCURRED THROUGH THE ¿LID¿, EVEN WHEN CLOSED. THIS WAS THE SECOND BUTTON EXCHANGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393352 ↗
• MalfunctionMar 9, 2017Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD THE 18FR, 1.7 CM TUBE- LOW PROFILE GASTRONOMY BUTTON. THE PATIENT¿S MOTHER NOTED LEAKING THROUGH THE ¿SKIN HOLE¿, BUT THEN NOTED THE LEAK OCCURRED THROUGH THE ¿LID¿, EVEN WHEN CLOSED. THIS WAS THE THIRD BUTTON EXCHANGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393351 ↗
• MalfunctionMar 9, 2017Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD THE 18FR, 1.7 CM TUBE- LOW PROFILE GASTRONOMY BUTTON. THE REPLACEMENT BUTTON WAS PLACED ON (B)(6) 2017. THE SAME MODEL WAS USED FOR THE REPLACEMENT. THE PATIENT¿S MOTHER NOTED LEAKING THROUGH THE ¿SKIN HOLE¿, BUT THEN NOTED THE LEAK OCCURRED THROUGH THE ¿LID¿, EVEN WHEN CLOSED. THIS WAS THE FOURTH BUTTON EXCHANGE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393279 ↗
• MalfunctionJan 6, 2016Break

  PER MS&S, PATIENT'S MOTHER CALLED AND WANTED TO CONFIRM HOW BIG THE INTERNAL BOLSTER IS FOR THE 18FR 1.7CM BARD BUTTON. SHE STATED THIS BUTTON WAS IN PLACE FOR OVER ONE YEAR, BUT DURING THE REMOVAL PROCESS THE SHAFT BROKE AWAY FROM THE EXTERNAL PORTION OF THE BUTTON. THE SHAFT AND INTERNAL BOLSTER ARE INSIDE THE STOMACH. MS&S STATED THAT THE WIDEST PORTION OF THIS INTERNAL BOLSTER IS 0.56". MS&S EXPLAINED THAT SHE WOULD NEED TO REPORT IT TO FA, BUT WHEN ASKED FOR HER CONTACT INFORMATION, SHE WAS NOT WILLING TO SHARE IT. SHE STATED "SHE WOULD HAVE THE DOCTOR CALL", THEN HUNG UP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5349395 ↗