Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ EN0046160Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741113253), received between May 31, 2018 and Feb 14, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

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-0799-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702037 ↗
• MalfunctionNov 27, 2023Incorrect Measurement; Fitting Problem; Incorrect Measurement; Fitting Problem

  IT WAS REPORTED THAT NASOGASTRIC SUMP TUBE AND IT HAS THE ENFIT DEVICE ON IT. WHAT THEY WERE TRYING TO FIGURE OUT WAS HOW TO CONNECT IT SUCTION BECAUSE THE LUER LOCK DECREASED THE DIAMETER OF THE TUBE (EN0046160 AND EN0066000).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209856 ↗
• InjuryJun 8, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS A RECENT INCIDENT WHERE ONE OF THEIR PROVIDERS WAS USING EN0046160 FOR DECOMPRESSION. UNFORTUNATELY, THEY HAD AN EVENT IN WHICH ONE OF THESE BARD TUBES WAS PLACED IN A PATIENT WHO WAS ACTIVELY CODING. THEY WERE UNABLE TO DECOMPRESS THE PATIENT¿S STOMACH AND ENDED UP USING SCISSORS TO CUT THE END OF IT OFF TO CONNECT SUCTION. IN DOING SO, THE CRISIS NURSE ALSO HAD GASTRIC CONTENTS SPRAYED ALL OVER THEM. THEY WERE AWARE THAT THERE WERE ADAPTER OPTIONS BUT STATED THEY COULD NOT DECOMPRESS THROUGH THE SMALL ENFIT HOLE. THEY WOULD ASSUME THIS TUBE WOULD ALSO HAVE PROBLEMS IN OTHER SITUATIONS, SUCH AS BLEEDING OR POISONING SITUATIONS. THIS WAS A MAJOR PATIENT SAFETY EVENT. IF THE PRODUCT WAS UNABLE TO DO WHAT IT WAS SUPPOSED TO DO, THEY HAD A PROBLEM. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, IT WAS REPORTED THAT THE SAMPLE WAS DISCARDED. THEY DID NOT THINK THE BARD SOLUTION WOULD MEET THE ANESTHESIOLOGISTS¿ NEEDED IN AN EMERGENCY. ALSO STATED THAT THIS TUBE WAS NEEDED DURING A CODE. ULTIMATELY BECAUSE THE STAFF DIDN¿T HAVE THE ADAPTERS, THEY NEEDED TO CUT OFF THE FIXED ENFIT ADAPTER TO UTILIZE THE SUCTION FEATURE. THERE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Exposure to Body Fluids

  MAUDE report 17086018 ↗
• MalfunctionMay 8, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT PROVIDER ATTEMPTED TO PLACE A NASOGASTRIC TUBE (NG TUBE) (THE NEW ENFIT STYLE THAT WE HAVE JUST STARTED TO CARRY) 16 FR OR 18 FR AND HAD THE FIRST 3 NASOGASTRIC TUBES CLOG (BATCH# NGGR2656), WAS SUCCESSFUL ON THE 4TH TUBE. PER FOLLOW-UP VIA EMAIL ON 10-MAY-2023, IT WAS REPORTED THAT THE NEW BD ENFIT COMPATIBLE SUMP TUBES HAD AN ENFIT TIP ON THEM WHICH REQUIRED A SUCTION ADAPTER TO PERFORM SUCTION. THE PORT AND ADAPTER HAD A NARROW CHANNEL AND BRONSON CLINICIANS HAD REPORTED CLOGGING ISSUES (BATCH# NGFW1855). PER FOLLOW UP VIA PHONE ON 02-JUN-2023, CUSTOMER HAS ISSUES WITH TWO LOTS NNGY3160 AND NNGV4485 THE CUSTOMER HAS A SAMPLE TO SEND IN AND THE ONLY PATIENT IMPACT WAS THAT CATHETERS HAD TO BE RE-INSERTED, BUT NO HARM TO ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886173 ↗
• 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 15508528 ↗
• MalfunctionFeb 11, 2020Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

  IT WAS REPORTED THAT THE OPENING WAS TOO NARROW TO EFFECTIVELY DRAIN THE STOMACH.

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

  MAUDE report 9695650 ↗
• MalfunctionMay 31, 2018Suction Problem

  IT WAS REPORTED THAT THE NG TUBE DID 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 7557792 ↗