Bard® Nasogastric Sump Tube with Enfit™ EN0042180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741113819), received between Jun 13, 2023 and Jun 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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-0794-2024 · 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.

• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES WHEN USED FOR SUCTION. STATED THAT IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES AND THEY HAVE REACHED OUT TO THEIR AHS PARTNERS, AND THEY ALSO SEEM TO HAVE THE SAME ISSUE. AS PER FOLLOW-UP VIA EMAIL ON 23MAY2023, IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE NEW ENFIT NASOGASTRIC TUBES (EN0042180) (EN0042120, EN0042140 , EN0042160 ) WHEN USED FOR SUCTION. IT SEEMS THAT WHEN THE DRAINAGE WAS THICK OR CONTAINS FOOD PARTICLES THE SUCTION DID NOT WORK BECAUSE THE ENFIT OPENING WAS CONSIDERABLY SMALLER THAN THE LEGACY NASOGASTRIC TUBE OPENING. THEIR OPERATING ROOM (OR) STAFF FELT THAT THEY WERE NOT ABLE TO QUICKLY DECOMPRESS THE STOMACH WITH THE ENFIT NASOGASTRIC TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117355 ↗
• MalfunctionJun 13, 2023Incorrect Measurement; Suction Failure; Incorrect Measurement; Suction Failure

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE SMALLER BORE SIZE ON THE ENFIT CONNECTORS. THE CUSTOMER ASKED FOR LUMEN SIZES OF EN0042180 AND EN0056180 AS THEY WERE ADVISING THAT STOMACH DEBRIS FROM PATIENTS WAS CLOGGING THE TUBING BECAUSE PATIENTS WITH A FULL STOMACH COULD NOT BE SUCTIONED USING THE ENFIT CONNECTOR. FOR NOW, THEY WERE KEEPING A CASE OF THE STANDARD VERSION IN CASE THE ENFIT DID NOT WORK FOR THEM. PER FOLLOW UP VIA EMAIL RECEIVED ON 26MAY2023, CUSTOMER HAD MADE IT CLEAR SEVERAL TIMES THAT THESE WERE MERELY REPORTED EVENTS SURROUNDING THE PROBLEM OF THE SUMP TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17116877 ↗