Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ EN0056160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741113864), received between Mar 29, 2019 and Feb 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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-0804-2024 · 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. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701844 ↗
• MalfunctionDec 28, 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. THEY WERE CONCERNED ABOUT THE REPEATED INVASIVE PROCEDURE THAT CAN CAUSE TRAUMA, DISCOMFORT, PATIENT DISSATISFACTION AND REPEATED EXPOSURE TO RADIATION. 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. STATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410268 ↗
• MalfunctionMar 29, 2019Complete Blockage; Incorrect Measurement; Inadequacy of Device Shape and/or Size; Suction Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE SUMP TUBES WITH ENFIT CONNECTION HAD A SMALLER INTERNAL DIAMETER THAN THE TUBES THEY HAD PREVIOUSLY RECEIVED. THE NURSES HAVE STATED THAT THEY WERE HAVING A HARD TIME GETTING ADEQUATE SUCTION DUE TO THE SMALLER SIZE AND AS A RESULT THE TUBES WERE GETTING CLOGGED WHEN THERE WERE LARGE FOOD PARTICLES AND/OR PILL PARTICLES IN THE GASTRIC CONTENTS. THIS WAS A COMMON OCCURRENCE IN THE EMERGENCY DEPARTMENT AND FOR PATIENT'S GOING EMERGENTLY TO THE OPERATING ROOM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8467207 ↗