Bard® Nasogastric Sump Tube with Enfit™ EN0042140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741113796), received between Jun 13, 2023 and Jun 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (3 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-0792-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CUSTOMER HAD ANOTHER PROBLEM LAST NIGHT. THE TUBE BEGAN TO LEAK FROM ANTI-REFLUX TUBING. UPON ASPIRATING, THE ANTI-REFLUX PORT DRAINED FLUID, BUT THE SUCTION PORT DID NOT HAVE ANY DRAINAGE WHEN ASPIRATED. IT TOOK IRRIGATION OF THE PORT FOR IT TO FINALLY START DRAINING THROUGH THE SUCTION PORT INSTEAD OF THE ANTI-REFLUX PORT. PER FOLLOW UP VIA EMAIL ON 03JUN2023, THE DRAIN TIME OF THE NASOGASTRIC TUBE WAS UNKNOWN AS THE PATIENT CAME FROM THE ER. IT WAS NOT PROVIDING SUCTIONING TO THE PATIENT, THEY WERE ABLE TO IDENTIFY THE ISSUE DUE TO THE LEAKAGE. THIS COULD HAVE BEEN A POTENTIAL SAFETY ISSUE FOR THE PATIENT. HENCE, IF THE LEAKING DID NOT OCCUR, THE NURSES COULD HAVE THOUGHT THE PATIENT HAD STOPPED HAVING OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181625 ↗
• MalfunctionJun 19, 2023Inaccurate Flow Rate; Suction Failure; Inaccurate Flow Rate; Suction Failure

  IT WAS REPORTED THAT THE CUSTOMER HAD ANOTHER PROBLEM LAST NIGHT. THE TUBE BEGAN TO LEAK FROM ANTI-REFLUX TUBING. UPON ASPIRATING, THE ANTI-REFLUX PORT DRAINED FLUID, BUT THE SUCTION PORT DID NOT HAVE ANY DRAINAGE WHEN ASPIRATED. IT TOOK IRRIGATION OF THE PORT FOR IT TO FINALLY START DRAINING THROUGH THE SUCTION PORT INSTEAD OF THE ANTI-REFLUX PORT. PER FOLLOW UP VIA EMAIL ON 02JUN2023, THE DRAIN TIME OF THE NASOGASTRIC TUBE WAS UNKNOWN AS THE PATIENT CAME FROM THE ER. IT WAS NOT PROVIDING SUCTIONING TO THE PATIENT, THEY WERE ABLE TO IDENTIFY THE ISSUE DUE TO THE LEAKAGE. THIS COULD HAVE BEEN A POTENTIAL SAFETY ISSUE FOR THE PATIENT. HENCE, IF THE LEAKING DID NOT OCCUR, THE NURSES COULD HAVE THOUGHT THE PATIENT HAD STOPPED HAVING OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17156750 ↗
• MalfunctionJun 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THAT THE CUSTOMER HAD ANOTHER PROBLEM LAST NIGHT. THE TUBE BEGAN TO LEAK FROM ANTI-REFLUX TUBING. UPON ASPIRATING, THE ANTI-REFLUX PORT DRAINED FLUID, BUT THE SUCTION PORT DID NOT HAVE ANY DRAINAGE WHEN ASPIRATED. IT TOOK IRRIGATION OF THE PORT FOR IT TO FINALLY START DRAINING THROUGH THE SUCTION PORT INSTEAD OF THE ANTI-REFLUX PORT. PER FOLLOW UP VIA EMAIL ON 02JUN2023. THE DRAIN TIME OF THE NASOGASTRIC TUBE WAS UNKNOWN. AS THE PATIENT CAME FROM THE ER. IT WAS NOT PROVIDING SUCTIONING TO THE PATIENT. THEY WERE ABLE TO IDENTIFY THE ISSUE, DUE TO THE LEAKAGE. THIS COULD HAVE BEEN A POTENTIAL SAFETY ISSUE FOR THE PATIENT, HENCE, IF THE LEAKING DID NOT OCCUR. THE NURSES COULD HAVE THOUGHT THE PATIENT HAD STOPPED HAVING OUTPUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153421 ↗
• 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 (12FR. 14FR , 16FR) 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 17116999 ↗