Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ EN0046140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741113246), received between May 31, 2018 and Feb 14, 2024 — classified as 4 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 20, 2023Class IIOpen, Classified

   BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

   Z-0798-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE HAD UNKNOWN ISSUE. (EN0046140, EN0046160)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702035 ↗
• MalfunctionJul 10, 2023Increase in Suction; Suction Failure; Increase in Suction; Suction Failure

  IT WAS REPORTED THAT THE CUSTOMER HAD AN INCIDENT WITH THE NEW ENFIT NG TUBES. DESPITE BARD HAVING IN THEIR PACKAGE INSERT THAT THEY WERE APPROVED FOR GASTRIC DECOMPRESSION, IT FAILED THAT PURPOSE. THE PATIENT HAD THE NG FOR GASTRIC DECOMPRESSION. IT WAS SET ON LOW INTERMITTENT SUCTION WHILE THE PATIENT WAS ON CICU, AND CHARTING INDICATED THAT IT WAS WORKING APPROPRIATELY AT THAT POINT WITH EXPECTED AMOUNTS OF GASTRIC OUTPUT. WHEN THE PATIENT WAS TAKEN TO SURGERY, THE SUCTION WAS INCREASED TO HIGH (NOT SURE IF CONTINUOUS OR INTERMITTENT) AND IT NO LONGER DRAINED GASTRIC OUTPUT. THE SUCTION TUBING THE NG WAS ATTACHED TO WAS REPORTED TO COLLAPSE IN. THE NG TUBE HAD TO BE REPLACED, AND WAS REPLACED WITH A NON-ENFIT VERSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289178 ↗
• MalfunctionSep 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE DID NOT DO WHAT INTENDED IN MEDICAL SETTING. THE ISSUE WITH THE NASOGASTRIC TUBE WAS UNKNOWN. THE PRODUCT CATALOG NUMBERS PROVIDED BY CUSTOMER WERE EN0046100, EN0046120, EN0046140, EN0046160 AND EN0046180.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508466 ↗
• MalfunctionMay 31, 2018Suction Problem

  IT WAS REPORTED THAT THE NG TUBE DO NOT SUCTION WELL. THE COMPLAINANT REPORTED THAT THE NURSING STAFF HAD TO BREAK THE "INNER MOAT" SECTION OUT OF THE ENFIT CONNECTOR TO IMPROVE THE SUCTION.

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

  MAUDE report 7557780 ↗