Bard Button Device Bolus Feeding Tube with Straight Adaptor 000259Recalls & reported problems
Bard Access Systems, Inc. · Bolus Tube for 24 Fr · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741080852), received between Oct 26, 2020 and Jun 21, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress2
- Dent in Material1
- Difficult to Flush1
- Fluid/Blood Leak1
- Material Deformation1
- Obstruction of Flow1
- Restricted Flow rate1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2022Difficult to Flush; Obstruction of Flow; Dent in Material; Deformation Due to Compressive Stress; Material Deformation; Difficult to Flush; Obstruction of Flow; Dent in Material; Deformation Due to Compressive Stress; Material Deformation
IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CLOGGED. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD ISSUES WITH PINCHING AND STAYING INDENTED EVEN AFTER STRAIGHTENING OUT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14751533 ↗MalfunctionOct 26, 2020Restricted Flow rate; Restricted Flow rate
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000259 GASTRO-ENTEROSTOMY TUBE ALLEGEDLY EXPERIENCED RESTRICTED FLOW RATE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10737564 ↗MalfunctionOct 26, 2020Fluid/Blood Leak; Deformation Due to Compressive Stress; Fluid/Blood Leak; Deformation Due to Compressive Stress
THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 000259 FEEDING TUBE ALLEGEDLY HAD FLUID LEAK AND DEFORMATION DUE TO COMPRESSIVE STRESS. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN A MALE PATIENT. AGE AND WEIGHT OF THE PATIENT WAS NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10737536 ↗
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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