Bard® Suction Connector EN0066000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741128707), received between Apr 27, 2022 and Feb 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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-0806-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 18701936 ↗
• MalfunctionNov 28, 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 18220499 ↗
• MalfunctionMay 12, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW IF THERE WAS ANY RISK WITH RESTRICTED SUCTION CAUSED BY DEBRIS CLOGGING THE SMALLER SUCTION ADAPTER ON THE NASOGASTRIC TUBES. IT WAS RECOMMENDED TO PERIODICALLY STOP SUCTION, IRRIGATE AND THEN CONTINUE SUCTIONING AND WAS TOLD THAT IT HAD BEEN A PERCEIVED RISK THAT THEY HAVE HEARD BUT NOT OF ANYONE ENCOUNTERING IT. CUSTOMER STATED THAT THEY HAVE FILED AT LEAST ONE MEDSUN REPORT THAT WEEK BECAUSE OF CLOGGING ISSUES THAT WERE OCCURRING FREQUENTLY AND WANTED TO KNOW ALL DOCUMENTED STEPS FOR RESOLVING CLOGS THAT BD HAD EXPLORED. PER FOLLOW VIA PHONE 29MARCH2023, CUSTOMER STATES THEY ARE STILL HAVING THE ISSUES AND THAT IT APPEARS THE ISSUES OCCURS MORE DURING POST OP AS PATIENTS MAY HAVE BLOOD CLOTS THAT GET STUCK DURING IRRIGATION. NO ADDITIONAL MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919228 ↗
• MalfunctionMay 4, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER WERE EXPERIENCED DIFFICULTIES IN REMOVING SUCTION TUBING FROM THE NASOGASTRIC TUBE ONCE IT HAS BEEN CONNECTED. CUSTOMER ALSO STATED THAT THEY HAD BILE AND SECRETIONS CAME OUT OF THE ANTIREFLUX VALVE END OF THE TUBE WHICH WAS GETTING ON PATIENTS AND BEDDING . CUSTOMER ASKED IS THERE SOME SORT OF POSITIONING THAT THEY NEED TO DO TO HELP WITH THIS PROBLEM. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07APR2022, CUSTOMER STATED THAT THE ENFIT TUBES DID NOT HAVE THE PREVENT FILTER ATTACHED. STATED THAT IT WAS THE LITTLE DISC SHAPED INTEGRAL PLUG COMPONENT AT THE END OF THE PIGTAIL. INQUIRER RESPONDED THAT THE PLUG WAS JUST FOR WHEN THEY WERE TRANSPORTING THE PATIENT AND NOT SURE WHY THE ENFIT VERSION DID NOT INCLUDE IT. INQUIRER ASSUMED THAT THERE WAS AN ENGINEERING REASON BUT COULD NOT SAID FOR SURE, IT SHOULD NOT HAVE ANY IMPACT ON THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282030 ↗
• MalfunctionApr 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER WERE EXPERIENCED DIFFICULTIES IN REMOVING SUCTION TUBING FROM THE NASOGASTRIC TUBE ONCE IT HAS BEEN CONNECTED . IT WAS ALSO STATED THAT THEY HAVE HAD BILE AND THE SECRETIONS CAME OUT OF THE ANTIREFLUX VALVE END OF THE TUBE WHICH WAS GETTING ON PATIENTS AND BEDDING . CUSTOMER ASKED IS THERE SOME SORT OF POSITIONING THAT THEY NEED TO DO TO HELP WITH THIS PROBLEM . AS PER THE ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07APR2022, CUSTOMER STATED THAT THE ENFIT TUBES DID NOT HAVE THE PREVENT FILTER ATTACHED. STATED THAT IT WAS THE LITTLE DISC SHAPED INTEGRAL PLUG COMPONENT AT THE END OF THE PIGTAIL. INQUIRER RESPONDED THAT THE PLUG WAS JUST FOR WHEN THEY WERE TRANSPORTING THE PATIENT AND NOT SURE WHY THE ENFIT VERSION DID NOT INCLUDE IT. INQUIRER ASSUMED THAT THERE WAS AN ENGINEERING REASON BUT COULD NOT SAY FOR SURE. IT SHOULD NOT HAVE ANY IMPACT ON THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220197 ↗
• MalfunctionApr 27, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WERE EXPERIENCED DIFFICULTIES IN REMOVING SUCTION TUBING FROM THE NASOGASTRIC TUBE ONCE IT HAS BEEN CONNECTED. CUSTOMER ALSO STATED THAT THEY HAD BILE AND SECRETIONS CAME OUT OF THE ANTIREFLUX VALVE END OF THE TUBE WHICH WAS GETTING ON PATIENTS AND BEDDING. CUSTOMER ASKED IS THERE SOME SORT OF POSITIONING THAT THEY NEED TO DO TO HELP WITH THIS PROBLEM . PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07APR2022, CUSTOMER STATED THAT THE ENFIT TUBES DID NOT HAVE THE PREVENT FILTER ATTACHED. STATED THAT IT WAS THE LITTLE DISC SHAPED INTEGRAL PLUG COMPONENT AT THE END OF THE PIGTAIL. INQUIRER RESPONDED THAT THE PLUG WAS JUST FOR WHEN THEY WERE TRANSPORTING THE PATIENT AND NOT SURE WHY THE ENFIT VERSION DID NOT INCLUDE IT. INQUIRER ASSUMED THAT THERE WAS AN ENGINEERING REASON BUT COULD NOT SAY FOR SURE. IT SHOULD NOT HAVE ANY IMPACT ON THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220078 ↗