Bard® Nasogastric Sump Tube with Enfit™ EN0042160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741113802), received between May 30, 2023 and May 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (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-0793-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMay 31, 2023Decrease in Suction; Suction Failure; Decrease in Suction; Suction Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032259 ↗
• MalfunctionMay 30, 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) 16FR OR 18FR AND HAD THE FIRST 3 NASOGASTRIC TUBES CLOG (BATCH# NGGR2656) , WAS SUCCESSFUL ON THE 4TH TUBE. PER FOLLOW-UP VIA EMAIL ON 10MAY2023, 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 02JUN2023, CUSTOMER HAS ISSUES WITH TWO LOTS NNGY3160AND 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 17020614 ↗