Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ EN0056140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741113857), received between Dec 27, 2023 and Feb 14, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (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-0803-2024 · 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.

• 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 18702039 ↗
• MalfunctionJan 4, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CURRENTLY STOCKED BARD SUMP NASOGASTRIC TUBES WERE NOT DRAINING APPROPRIATELY WHEN CONNECTED TO SUCTION DRAINAGE. CUSTOMER WAS TOLD OF UP TO 4 INSTANCES WHERE THE TUBE HAD TO BE REPLACED SHORTLY AFTER BEING PLACED DUE TO CLOGGING OR NOT DRAINING. THIS RESULTED IN DELAYS IN CARE FOR THEIR PATIENT (I.E. DRAINAGE OF STOMACH CONTENTS), AND DISSATISFACTION WITH MULTIPLE INVASIVE PROCEDURES TO REPLACE TUBES, NOT TO MENTION THE ADDITIONAL X-RAYS EXPOSURE REQUIRED TO VERIFY TUBE PLACEMENT. COMPARED TO THE COVIDIEN NG SALEM SUMP TUBES CUSTOMER HAD BEEN USING, THE SIZE OF THE HOLE TO ALLOW DRAINAGE FROM SUCTION WAS SIGNIFICANTLY SMALLER IN THE BARD. THERE WAS ANOTHER SET OF STAFF WITH THE SAME CONCERNS. CUSTOMER HAD MULTIPLE AREAS EXPRESSED CONCERNS WITH THE BARD SUB FOR THE NASOGASTRIC TUBES. CUSTOMER THOUGHT THE BARD TUBE SHOULD BE PULLED FROM USE IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445706 ↗
• InjuryJan 2, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CURRENTLY STOCKED BARD SUMP NASOGASTRIC TUBES WERE NOT DRAINING APPROPRIATELY WHEN CONNECTED TO SUCTION DRAINAGE. CUSTOMER WAS TOLD OF UP TO 4 INSTANCES WHERE THE TUBE HAD TO BE REPLACED SHORTLY AFTER BEING PLACED DUE TO CLOGGING OR NOT DRAINING. THIS RESULTED IN DELAYS IN CARE FOR THEIR PATIENT (I.E. DRAINAGE OF STOMACH CONTENTS), AND DISSATISFACTION WITH MULTIPLE INVASIVE PROCEDURES TO REPLACE TUBES, NOT TO MENTION THE ADDITIONAL X-RAYS EXPOSURE REQUIRED TO VERIFY TUBE PLACEMENT. COMPARED TO THE COVIDIEN NG SALEM SUMP TUBES CUSTOMER HAD BEEN USING, THE SIZE OF THE HOLE TO ALLOW DRAINAGE FROM SUCTION WAS SIGNIFICANTLY SMALLER IN THE BARD. THERE WAS ANOTHER SET OF STAFF WITH THE SAME CONCERNS. CUSTOMER HAD MULTIPLE AREAS EXPRESSED CONCERNS WITH THE BARD SUB FOR THE NASOGASTRIC TUBES. CUSTOMER THOUGHT THE BARD TUBE SHOULD BE PULLED FROM USE IMMEDIATELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14DEC2023, IT WAS REPORTED THAT THE NASOGASTRIC TUBE HAVING ISSUES WITH CLOGGING AS THEY USED SUCTION. STATED THAT TO ADD THE ADAPTOR CAUSED THE TUBING TO NARROW AND THIS WAS A HUGE SAFETY CONCERN. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15DEC2023, IT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18427281 ↗
• InjuryDec 27, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CURRENTLY STOCKED BARD SUMP NASOGASTRIC TUBES WERE NOT DRAINING APPROPRIATELY WHEN CONNECTED TO SUCTION DRAINAGE. CUSTOMER WAS TOLD OF UP TO 4 INSTANCES WHERE THE TUBE HAD TO BE REPLACED SHORTLY AFTER BEING PLACED DUE TO CLOGGING OR NOT DRAINING. THIS RESULTED IN DELAYS IN CARE FOR THEIR PATIENT (I.E. DRAINAGE OF STOMACH CONTENTS), AND DISSATISFACTION WITH MULTIPLE INVASIVE PROCEDURES TO REPLACE TUBES, NOT TO MENTION THE ADDITIONAL X-RAYS EXPOSURE REQUIRED TO VERIFY TUBE PLACEMENT. COMPARED TO THE COVIDIEN NG SALEM SUMP TUBES CUSTOMER HAD BEEN USING, THE SIZE OF THE HOLE TO ALLOW DRAINAGE FROM SUCTION WAS SIGNIFICANTLY SMALLER IN THE BARD. THERE WAS ANOTHER SET OF STAFF WITH THE SAME CONCERNS. CUSTOMER HAD MULTIPLE AREAS EXPRESSED CONCERNS WITH THE BARD SUB FOR THE NASOGASTRIC TUBES. CUSTOMER THOUGHT THE BARD TUBE SHOULD BE PULLED FROM USE IMMEDIATELY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14DEC2023, IT WAS REPORTED THAT THE NASOGASTRIC TUBE HAVING ISSUES WITH CLOGGING AS THEY USED SUCTION. STATED THAT TO ADD THE ADAPTOR CAUSED THE TUBING TO NARROW AND THIS WAS A HUGE SAFETY CONCERN. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15DEC2023, IT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 18400442 ↗