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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

All TUBE, GASTRO-ENTEROSTOMY devices →

Sources and updates

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