Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ EN0056180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741113871), received between Jun 13, 2023 and Feb 14, 2024 — classified as 3 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-0805-2024 · 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.

• MalfunctionFeb 14, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE NASOGASTRIC TUBES HAD UNKNOWN ISSUE. (EN0056120) (EN0056140) (EN0056160) (EN0056180) (EN0066000)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701933 ↗
• MalfunctionAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING A CONCERN WITH THE NG TUBE LEAKING AND WAS HOPING TO SCHEDULE A VIDEO CONFERENCE WITH TO REVIEW THE CONCERN AND PROVIDE EDUCATION ON HOW TO PREVENT THIS ISSUE AS THEY THOUGHT THEY WERE NOT FLUSHING IT PROPERLY. THE SALEM SUMPS WERE LEAKING AND ONE OF THE PROVIDERS JUST CUT OFF THE VALVE AND CAPPED IT, AND WERE HOPING FOR A QUICK REVIEW ON HOW TO MAINTAIN THE SUMP SO THEY DO NOT LEAK ON THE PATIENT. PER FOLLOW UP VIA EMAIL ON 24JUL2023, CUSTOMER STATED THAT NO PATIENT INJURY HAD OCCURRED, ALSO FOUND THAT THE ENFIT CAUSED FLUID TO LEAK BACK UP THE AIR LUMEN WHEN A PATIENT HAD THE SALEM SLUMP ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450313 ↗
• 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 (B)(6) AND (B)(6) 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 17116900 ↗