Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046140Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741052316), received between Aug 31, 2017 and Mar 10, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS BLACK DEBRIS IN THE NASOGASTRIC TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558848 ↗
• MalfunctionSep 3, 2024Unclear Information; Unclear Information

  IT WAS REPORTED THAT THE NEWER MODELS OF NASAL GASTRIC TUBES DID NOT HAVE MARKING NUMBERS INDICATING HOW FAR THE TUBE HAD BEEN INSERTED. THERE WERE JUST BLACK MARKS THUS LEADING TO CONFUSION IF THE TUBE WAS STILL PLACED IN THE CORRECT SPOT. THEY WERE UNABLE TO FIND ANOTHER NG TUBE ON THE WEBSITE PRODUCT LIST WITH NUMBER MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126481 ↗
• MalfunctionSep 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS INSERTED IN ONE OF THEIR PATIENTS IN THE ICU THIS PAST WEEKEND AND DISCOVERED TO BE DEFECTIVE. CUSTOMER STATED THAT THERE WAS A HOLE UNDER THE BLUE ANTI- REFLUX TUBE OR VALVE AND GASTRIC CONTENTS WERE LEAKED FROM THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763784 ↗
• MalfunctionMar 29, 2022Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE CAME WITH A PIECE OF CONNECTOR. CUSTOMER STATED THAT AFTER IT WAS USED ON THE PATIENT FOR A WHILE, THE TUBE GOT SOFTENED AND THE CONNECTOR WOULD GET PUSHED FURTHER DOWN AND EVENTUALLY OBSTRUCT THE REFLUX VENT. IT WAS STATED THAT AT MOST TIMES, THE NURSE COULD FISH OUT THE CONNECTOR USING HEMOSTAT. HOWEVER, IF UNABLE TO PULL IT OUT, THE ENTIRE NASOGASTRIC TUBE MUST BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935360 ↗
• MalfunctionMar 29, 2022Component Misassembled; Material Too Soft/Flexible; Component Misassembled; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE CAME WITH A PIECE OF CONNECTOR. CUSTOMER STATED THAT AFTER A WHILE OF BEING USED ON THE PATIENT, THE TUBE GOT SOFTENED AND THE CONNECTOR WAS BEING PUSHED FURTHER DOWN TO EVENTUALLY OBSTRUCT THE REFLUX VENT. STATED THAT THE ISSUE HAS BEEN KNOWN TO STAFF IN MEDICAL/SURGERY UNIT. ALSO AT MOST TIMES, NURSE COULD FISH OUT THE CONNECTOR USING HEMOSTAT. HOWEVER, IF UNABLE TO PULL IT OUT, THE ENTIRE NASOGASTRIC TUBE MUST BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935348 ↗
• MalfunctionDec 1, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT HAD ARRIVED AT THE UNIT ON ADMISSION WITH A CLAMPED NASOGASTRIC TUBE FROM THE EMERGENCY DEPARTMENT AND WAS TO BE RECONNECTED TO LOW SUCTION FOR DECOMPRESSION, BUT THE STAFF WERE UNABLE TO REMOVE THE CLAMP AS IT WAS FULLY LODGED INTO THE NASOGASTRIC TUBING. IT WAS THEN STATED THAT THE NASOGASTRIC TUBE CLAMP PIECE WHICH IS THE WHITE END OF THE BLUE OR THE WHITE CLAMP PIECE BROKE OFF AND WAS STUCK IN NASOGASTRIC TUBING. COMPLAINANT STATED THAT IT BROKE QUITE EASILY AND THERE WAS NO WAY TO AVOID. LATER, A METAL CHEST TUBE CLAMP WAS USED TO REMOVE THE PIECE, ALTHOUGH IT WAS DIFFICULT. SOLVING THE PROBLEM DID NOT LEAVE THE PATIENT IN HARM, BUT THE NASOGASTRIC TUBING REMAINED INTACT AND ATTACHED TO LOW SUCTION WITH SUCCESS. HOWEVER, THE PATIENT WAS BECOMING INCREASINGLY NAUSEATED THROUGHOUT THIS TIME AS THE PATIENT REMAINED CLAMPED FOR A PROLONGED PERIOD PRIOR TO BEING ABLE TO CONNECT THE NASOGASTRIC TUBING TO LOW SUCTION.

  Patient problems: Nausea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909008 ↗
• MalfunctionSep 24, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF NASOGASTRIC TUBE. PER FOLLOW UP RECEIVED ON 30AUG2021 THE CUSTOMER STATED THAT ON ONE PATIENT THE NASOGASTRIC TUBE LEAKED THE GASTRIC CONTENT WHERE THE ANTI REFLUX PORT MEETS THE GASTRIC PORT AND ANOTHER PATIENT THERE WAS A CONTINUOUS WHISTLING SOUND THAT CAME FROM THE SAME AREA. IT WAS ALSO STATED THAT THE TUBE REMOVED FROM THE PATIENT AND EXPERIENCED TRAUMA OF HAVING ANOTHER ONE INSERTED WITH THE SAME ISSUE WHERE THE PLACEMENT WAS CONFIRMED FOR EACH INSERTION. THE TUBE WAS ULTIMATELY REMOVED THE SECOND TIME AND THE PATIENT REFUSED ANOTHER INSERTION WHICH DELAYED THE HEALING RELATED TO THE DIAGNOSIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12525678 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF A NASOGASTRIC TUBE. PER FOLLOW UP RECEIVED ON 30AUG2021 THE CUSTOMER STATED THAT ON ONE PATIENT THE NASOGASTRIC TUBE LEAKED THE GASTRIC CONTENT WHERE THE ANTI REFLUX PORT MEETS THE GASTRIC PORT AND ANOTHER PATIENT THERE WAS A CONTINUOUS WHISTLING SOUND THAT CAME FROM THE SAME AREA. IT WAS ALSO STATED THAT THE TUBE REMOVED FROM THE PATIENT AND EXPERIENCED TRAUMA OF HAVING ANOTHER ONE INSERTED WITH THE SAME ISSUE WHERE THE PLACEMENT WAS CONFIRMED FOR EACH INSERTION. THE TUBE WAS ULTIMATELY REMOVED THE SECOND TIME AND THE PATIENT REFUSED ANOTHER INSERTION WHICH DELAYED THE HEALING RELATED TO THE DIAGNOSIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508014 ↗
• MalfunctionAug 6, 2021Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE ROLLED UP BECAUSE THEY WERE NOT STIFF AS THEY USED TO BE AND CLOGGED MORE. THE DEFECTIVE DEVICE'S CATALOG NUMBERS ARE 0046140, 0046160 AND 0046180.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289667 ↗
• MalfunctionAug 6, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE ROLLED UP BECAUSE THEY WERE NOT STIFF AS THEY USED TO BE, AND THEY CLOGGED MORE. THE DEFECTIVE DEVICE'S CATALOG NUMBERS ARE 0046140, 0046160 AND 0046180.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289644 ↗
• MalfunctionJul 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STAFF WENT TO ASPIRATE A SALEM PUMP NASOGASTRIC TUBE. STATED THAT WHEN THE STAFF TRIED TO PULL THE SALEM SUMP ANTI -REFLUX VALVE, IT BROKE INTO TWO PIECES. THE USER ALSO STATED THAT ONE PIECE WAS STUCK IN THE SALEM SUMP PORT AND THE OTHER PIECE GOT STUCK IN THE AIR VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204033 ↗
• MalfunctionJul 28, 2020Material Puncture/Hole; No Flow; Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS INSERTED BUT NO DRAINAGE WAS COLLECTED. REMOVED THE TUBE AND NOTED TWO HOLES AT THE END OF TUBE.

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

  MAUDE report 10333513 ↗
• MalfunctionMay 22, 2020Material Split, Cut or Torn; Material Perforation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE NG TUBE NEAR THE WATER IRRIGATION PORT.

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

  MAUDE report 10083888 ↗
• MalfunctionOct 8, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT THE PHYSICIAN AND NURSE ATTEMPTED TO INSERT THE TUBE DOWN, AND IT WAS ALLEGED BY THE X-RAY THAT IT CURLED AROUND AND DIDN'T SLIDE/GLIDE DOWN LIKE IT SHOULD. IT ALLEGEDLY LODGED IN THE CLIENT AND TOOK THE PHYSICIAN AN HOUR TO GET IT BACK OUT. THE STAFF AND PHYSICIAN WERE WONDERING IF IT HAD TO DO WITH THE RATHER LARGE HOLE THAT WAS APPROX. 2 INCHES FROM THE TIP THAT THE OTHER TUBES DID NOT HAVE. THEY SAID THIS SEEMED TO BE NEW IN THE BATCH OF TUBES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166322 ↗
• MalfunctionOct 8, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PHYSICIAN AND NURSE ATTEMPTED TO INSERT THE TUBE DOWN AND ACCORDING TO THE X-RAY, IT CURLED AROUND AND DIDN'T SLIDE/GLIDE DOWN LIKE IT SHOULD. IT ALLEGEDLY LODGED IN THE CLIENT AND TOOK THE PHYSICIAN AN HOUR TO GET IT BACK OUT. THE STAFF AND PHYSICIAN WERE WONDERING IF IT HAD TO DO WITH THE RATHER LARGE HOLE, WHICH WAS APPROX. 2 INCHES FROM THE TIP THAT THE OTHER TUBES DO NOT HAVE. THEY SAID THIS SEEMED TO BE NEW IN THE BATCH OF TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165856 ↗
• MalfunctionMay 3, 2019Leak/Splash

  IT WAS REPORTED THAT THE NG TUBE LEAKED FROM WHERE IT CONNECTS TO THE TUBING.

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

  MAUDE report 8577488 ↗
• MalfunctionMay 2, 2019Leak/Splash

  IT WAS REPORTED THAT THE NG TUBE LEAKED FROM WHERE IT CONNECTS TO THE TUBING.

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

  MAUDE report 8575497 ↗
• MalfunctionMar 18, 2019Break

  IT WAS REPORTED THAT THE PLASTIC PIECE ON THE ¿PREVENT FILTER¿ VERY EASILY BREAKS OFF.

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

  MAUDE report 8429298 ↗
• MalfunctionJan 15, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PREVENT REFLUX FILTER WAS BREAKING OFF AT THE SITE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8249454 ↗
• MalfunctionAug 31, 2017Leak/Splash

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE WAS LEAKING FROM AN UNKNOWN LOCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6833709 ↗