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Bard® Rectal Tube 0006510Recalls & reported problems

C. R. Bard, Inc. · Bard® Rectal Tube · Class 2

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 00801741045974), received between Mar 27, 2018 and Sep 10, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Component Missing1
  • Device Contamination with Chemical or Other Material1
  • Inadequate or Insufficient Training1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 10, 2021Inadequate or Insufficient Training; Inadequate or Insufficient Training

    IT WAS REPORTED THAT THE DIGNISHEILD MANUAL WAS REVIEWED AND CUSTOMER WANTS TO FIND INFORMATION ABOUT WHAT SHOULD BE DONE IF THERE IS A TEAR IN THE RECTAL TUBE. ASKING IS IT ADVISED THAT THE AREA BE PATCHED UP OR SHOULD A NEW ONE BE PLACED?. ALSO STATED THAT IF THERE IS TEAR WOULD IT COMPROMISE THE BALLOON RETENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12453181 ↗
  • MalfunctionSep 8, 2021Component Missing; Component Missing

    IT WAS REPORTED THAT THE DIGNISHIELD MANUAL WAS REVIEWED AND CUSTOMER WANTED TO FIND INFORMATION ABOUT WHAT SHOULD BE DONE IF THERE WAS A TEAR IN THE RECTAL TUBE. ALSO ASKED WAS IT ADVISED THAT THE AREA BE PATCHED UP OR SHOULD A NEW ONE BE PLACED? ALSO STATED THAT, IF THERE WAS TEAR WOULD IT COMPROMISE THE BALLOON RETENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12441291 ↗
  • MalfunctionMar 27, 2018Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE TEAL CONNECTOR PIECE OF THE RECTAL TUBE HAD PIECES COMING OFF INTO THE TUBE. THE COMPLAINANT STATED THAT THERMO FISHER SCIENTIFIC "RE-ASSEMBLES" THE DEVICE BY ADDING A "REDUCER COMPONENT" AND AN ADDITIONAL TUBE. IT WAS REPORTEDLY NOTICED AFTER THE RE-ASSEMBLY.

    Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

    MAUDE report 7373428 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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