Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ EN0046120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741113239), received between May 31, 2018 and Sep 29, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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-0797-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• 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 15508596 ↗
• MalfunctionOct 21, 2019Fluid/Blood Leak; Leak/Splash; Material Puncture/Hole; Leak/Splash

  IT WAS REPORTED THAT A NASOGASTRIC TUBE LEAKED FROM A HOLE BY THE VENT PORT. THE PATIENT HAD A NASOGASTRIC TUBE PLACED IN THE EMERGENCY DEPARTMENT. ON ARRIVAL TO THE NURSING UNIT, THE TUBE WAS FOUND TO BE LEAKING FROM A HOLE BY THE VENT PORT. THE TUBE WAS REPLACED AND NO PATIENT HARM WAS REPORTED. IT WAS LATER REPORTED VIA EMAIL STATED A SECOND NASOGASTRIC TUBE FROM THE SAME LOT HAS THE SAME ISSUE BUT WAS DISCARDED.

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

  MAUDE report 9214246 ↗
• MalfunctionMay 31, 2018Break; Suction Problem; Device Operates Differently Than Expected; Suction Problem

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

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

  MAUDE report 7557788 ↗