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Bard Button Device Decompression Tube 000352Recalls & reported problems

Bard Access Systems, Inc. · 18 Fr x 3.4 Button Decompression Tube · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741080968), received between Mar 28, 2017 and Mar 30, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2017Break

    AS REPORTED BY THE FACILITY TO MS&S, "CUSTOMER REPORTS THE BUTTON DECOMPRESSION TIP BROKE WHEN THEY INSERTED IT INTO THE PATIENT'S BUTTON."

    Patient problems: No Information

    MAUDE report 6446432 ↗
  • MalfunctionMar 28, 2017Break

    THE FACILITY REPORTED THAT THE TIP OF THE 18FR DECOMPRESSION TUBE BROKE. IT WAS STATED THAT THIS CAUSED THEM TO HAVE TO USE A NEW ONE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6439923 ↗

Other TUBE, GASTRO-ENTEROSTOMY devices

All TUBE, GASTRO-ENTEROSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.