Bard Button Device Continuous Feeding Tube 90 degree Adaptor 000256Recalls & reported problems
Bard Access Systems, Inc. · Bard Button Device Continuous Feeding Tube with 90° Adapter 18F · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741080821), received between Oct 18, 2017 and Apr 18, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Discolored2
- Failure to Infuse1
- Fracture1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2019Fracture; Fracture
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 000256 FEEDING DEVICE EXPERIENCED A FRACTURE. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT WAS REPORTED AS A (B)(6)-YEAR-OLD FEMALE WEIGHING (B)(6) LBS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8529940 ↗MalfunctionMay 17, 2018Failure to Infuse; Material Deformation; Failure to Infuse; Material Deformation
IT WAS REPORTED THAT THE PATIENT'S EXTENSION TUBING ON THE BUTTON FEEDING DEVICE WAS ALLEGEDLY BENT. IT WAS FURTHER REPORTED THAT THIS BEND DID NOT ALLOW FORMULA FEEDING TO PASS THOUGH; HOWEVER IT ALLOWED WATER TO PASS WITHOUT COMPLICATION. REPORTEDLY, THE FEEDING DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7524515 ↗MalfunctionOct 23, 2017Material Discolored
PER SALES REP, THE FACILITY REPORTED THAT THE TUBING TURNED BLACK WHILE FORMULA WAS INFUSING TO THE G-TUBE. THE TUBING WAS REPLACED. THIS REPORT ADDRESSES TUBING ONE.
Patient problems: No Information
MAUDE report 6970580 ↗MalfunctionOct 23, 2017Material Discolored
PER SALES REP, THE FACILITY REPORTED THAT THE TUBING TURNED BLACK WHILE FORMULA WAS INFUSING TO THE G-TUBE. THE TUBING WAS REPLACED. THIS REPORT ADDRESSES TUBING TWO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6970576 ↗MalfunctionOct 18, 2017Leak/Splash
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 STATES THAT THE EXTENSION TUBE HAS A LEAK IN IT AND IT IS LEAKING ALL OVER. SHE STATES IT IS LEAKING FROM THE ACTUAL TUBE, NOT WHERE THE BAG ATTACHES TO THE TUBE, AND NOT THE OPENING. PATIENT WOULD LIKE THE EXTENSION TUBE PORTION OF THE DEVICE REPLACED NOT THE ENTIRE DEVICE. PATIENT WAS ADVISED TO CONTACT PHYSICIAN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6960104 ↗
Other TUBE, GASTRO-ENTEROSTOMY devices
- AVANOS 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY93 reports
- AVANOS 98432Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY72 reports
- Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death61 reports
- Halyard 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death40 reports
- Halyard 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY35 reports
- AVANOS 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY34 reports
- AVANOS 98430Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death29 reports
- Halyard 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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