Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046180Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741052347), received between Oct 18, 2018 and Jun 10, 2026 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Component Missing” (6 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER CALLED ON BEHALF OF ONE OF HER CLIENTS, SHE SAYS THAT THEY ORDERED A CASE, AND ON THE CASE, 6 OF THE NG TUBE WERE DEFECTED. THEY WERE ALL LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462559 ↗
• MalfunctionJan 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN NG [NASOGASTRIC] TUBE INSERTION, IT WAS DISCOVERED THAT THE NG TUBE, NEAR THE REFLUX VALVE TUBING WAS DEFECTIVE. ONCE INSERTED IT WAS NOTED THAT THE STOMACH CONTENTS BEGAN LEAKING OUT OF THE TUBING. THE NG TUBE WAS REMOVED WITHOUT INCIDENT, AND THE PRODUCT WAS INSPECTED BY THE CLINICAL PRACTICE SPECIALIST AND MATERIALS MANAGEMENT. A HOLE NEAR THE REFLUX VALVE TUBING WHERE IT CONNECTS TO THE MAIN TUBING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157545 ↗
• MalfunctionOct 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THEY HAD AN ISSUE TONIGHT WITH A DEFECT IN A PATIENT¿S NG TUBE (SALEM SUMP) ON GEN SURG, WHICH HAS RAISED CONCERN BECAUSE THE RAPID RESPONSE NURSE AND THEY HAD THE SAME ISSUE WITH ANOTHER PATIENT ABOUT A MONTH AGO. NOT SURE IF THIS WAS A MANUFACTURER DEFECT BUT WANTED TO PASS ALONG FOR REVIEW BECAUSE THESE TUBES ARE OFTEN QUITE DIFFICULT TO PLACE AND COULD BE A BIT TRAUMATIC FOR THE PATIENTS, SO HAVING TO REPLACE THEM BECAUSE OF A DEFECT THAT WAS PRESENT OUT OF THE PACKAGE WAS NOT IDEAL. THEY HAVE ATTACHED A PICTURE OF THE TUBE IN ITS PACKAGING SO THAT SUPPLY WAS AWARE OF WHAT ITEM THEY WERE TALKING ABOUT, AND THEN THEY ATTACHED A CLOSE UP OF THE LOCATION THAT THE DEFECT WAS HAPPENING. BOTH TIMES THE ISSUE HAD BEEN RIGHT WHERE THE BLUE ANTI-REFLUX VALVE CONNECTS TO THE MAIN PART OF THE TUBE. ESSENTIALLY, THE TUBE HAD A HOLE THAT WAS PRESENT IN THIS LOCATION (THAT WAS PRESENT WITHOUT ANY MANIPULATION BY THE STAFF). THE LOCATION OF THIS HOLE MEANS THAT THE TUBE WAS NOT ABLE TO HOLD PROPER SUCTION, AND THE TUBE CANNOT BE FLUSHED. WHEN ATTEMPTING TO FLUSH THE TUBE, THE WATER COMES SHOOTING OUT OF THIS HOLE INSTEAD OF CONTINUING DOWN THE TUBE WHERE IT WAS SUPPOSED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266851 ↗
• MalfunctionOct 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THEY HAD AN ISSUE TONIGHT WITH A DEFECT IN A PATIENT¿S NG TUBE (SALEM SUMP) ON GEN SURG, WHICH HAS RAISED CONCERN BECAUSE THE RAPID RESPONSE NURSE AND THEY HAD THE SAME ISSUE WITH ANOTHER PATIENT ABOUT A MONTH AGO. NOT SURE IF THIS WAS A MANUFACTURER DEFECT BUT WANTED TO PASS ALONG FOR REVIEW BECAUSE THESE TUBES ARE OFTEN QUITE DIFFICULT TO PLACE AND COULD BE A BIT TRAUMATIC FOR THE PATIENTS, SO HAVING TO REPLACE THEM BECAUSE OF A DEFECT THAT WAS PRESENT OUT OF THE PACKAGE WAS NOT IDEAL. THEY HAVE ATTACHED A PICTURE OF THE TUBE IN ITS PACKAGING SO THAT SUPPLY WAS AWARE OF WHAT ITEM THEY WERE TALKING ABOUT, AND THEN THEY ATTACHED A CLOSE UP OF THE LOCATION THAT THE DEFECT WAS HAPPENING. BOTH TIMES THE ISSUE HAD BEEN RIGHT WHERE THE BLUE ANTI-REFLUX VALVE CONNECTS TO THE MAIN PART OF THE TUBE. ESSENTIALLY, THE TUBE HAD A HOLE THAT WAS PRESENT IN THIS LOCATION (THAT WAS PRESENT WITHOUT ANY MANIPULATION BY THE STAFF). THE LOCATION OF THIS HOLE MEANS THAT THE TUBE WAS NOT ABLE TO HOLD PROPER SUCTION, AND THE TUBE CANNOT BE FLUSHED. WHEN ATTEMPTING TO FLUSH THE TUBE, THE WATER COMES SHOOTING OUT OF THIS HOLE INSTEAD OF CONTINUING DOWN THE TUBE WHERE IT WAS SUPPOSED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23266849 ↗
• MalfunctionAug 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT (B)(6) OPERATING ROOM TEAM STATED THAT THE NASOGASTRIC TUBE LOOKED LIKE THE TUBING WAS USED/WASHED WITH DIRTY WATER AND IT WAS DISGUSTING. THEY HAVE ASKED THE TEAM TO HOLD ONTO THE IMPACTED PRODUCT. AT THAT TIME, THEY WERE NOT AWARE OF ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850848 ↗
• MalfunctionAug 1, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  IT WAS REPORTED THAT THE PRODUCT APPEARS TO HAVE DEFECT ON THE NASOGASTRIC TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686658 ↗
• MalfunctionApr 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO OF THE NASOGASTRIC TUBE WITH THIS LOT NUMBER WERE LEAKING AND FOUND A SMALL HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21899412 ↗
• MalfunctionApr 18, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT NASOGASTRIC TUBE WHEN IT WAS CONNECTED TO THE SUCTION IT WAS NOT SUCTIONING, MADE A HISSING NOISE, AND LEAKING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865265 ↗
• MalfunctionApr 16, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT NASOGASTRIC TUBE WHEN IT WAS CONNECTED TO THE SUCTION IT WAS NOT SUCTIONING, MADE A HISSING NOISE, AND LEAKING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848883 ↗
• MalfunctionDec 13, 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. PER FOLLOW UP VIA EMAIL ON 26NOV2024, IT WAS REPORTED THAT THE ISSUE THAT THEY WERE FACING WAS THAT BARDS TUBES DID NOT HAVE CLEAR MARKINGS. THERE WERE SOME SMALL BLACK MARKINGS, BUT THEY WERE TOO FAR SPACED OUT TO BE SAFELY USED AND THERE WAS NOT A NUMBER MARKING WITH THE BLACK LINES. THE CAREGIVERS SWAP OUT EVERY 12 HOURS AND TO TELL THE NEXT CAREGIVER THAT THE NG TUBE WAS 3 CM FROM THE 3RD BLACK LINE DID NOT WORK BECAUSE THERE WAS NOWHERE TO CHART SOMETHING LIKE THAT WITH THEIR CURRENT EMR. THEIR CHARTING HAD THEM PUT HOW FAR THE LINE WAS INSERTED. TO FIGURE THAT OUT, THEY WOULD NEED TO KNOW HOW LONG THE TOTAL LINE WAS, MEASURE HOW MUCH OF THE LINE WAS OUT OF THE PATIENT AND THEN SUBTRACT THAT FROM THE TOTAL LINE AMOUNT. THEY HAD TRIED USING TAPE OR A MARKER TO MARK THE INSERTION POINT BUT THE TAPE MOVED WITH TIME AND THE MARKING FROM A MARKER OR TOO EA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924921 ↗
• MalfunctionOct 9, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJS3545, LOT #NGJT1055). PER CUSTOMER FOLLOW UP RECEIVED ON 03OCT2024, IT WAS REPORTED THAT THE ISSUE WAS NOTICED WHEN PULLING PRODUCT FROM STOCK TO BE USED IN THE KIT BUILD PROCESS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, IT WAS DETERMINED THAT THE PRODUCT IS UNOPENED, AND THE CUSTOMER REQUESTED A DISPOSITION AND CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408299 ↗
• MalfunctionOct 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJS3545, LOT #NGJT1055). PER CUSTOMER FOLLOW UP RECEIVED ON 03OCT2024, IT WAS REPORTED THAT THE ISSUE WAS NOTICED WHEN PULLING PRODUCT FROM STOCK TO BE USED IN THE KIT BUILD PROCESS. UPON FURTHER COMMUNICATION WITH THE CUSTOMER, IT WAS DETERMINED THAT THE PRODUCT IS UNOPENED, AND THE CUSTOMER REQUESTED A DISPOSITION AND CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398306 ↗
• MalfunctionOct 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJQ1906), (LOT #NGGY1944). PER CUSTOMER FOLLOW UP RECEIVED ON 03OCT2024, IT WAS REPORTED THAT THE ISSUE WAS FOUND WHEN PULLING THE PRODUCT FROM STOCK TO BE USED IN THEIR KITTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397248 ↗
• MalfunctionOct 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJT1055), (LOT #NGJQ0337). PER CUSTOMER FOLLOW UP RECEIVED ON 10OCT2024, IT WAS REPORTED THAT THE ISSUE WAS NOTICED WHEN PULLING PRODUCT FROM STOCK TO BE USED IN THEIR KIT BUILD PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397219 ↗
• MalfunctionOct 8, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJQ1906), (LOT #NGGY1944). PER CUSTOMER FOLLOW UP RECEIVED ON 03OCT2024, IT WAS REPORTED THAT THE ISSUE WAS FOUND WHEN PULLING THE PRODUCT FROM STOCK TO BE USED IN THEIR KITTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397145 ↗
• MalfunctionOct 7, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF NASOGASTRIC TUBES. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE WERE MISSING WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF THEIR KITS (LOT #NGJT1055, LOT #NGJQ0337). PER CUSTOMER FOLLOW UP RECEIVED ON 10OCT2024, IT WAS REPORTED THAT THE ISSUE WAS NOTICED WHEN PULLING PRODUCT FROM STOCK TO BE USED IN THEIR KIT BUILD PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382930 ↗
• MalfunctionJan 30, 2024Unclear Information; Unclear Information

  IT WAS REPORTED THAT PATIENT RECEIVED TUBE FEEDING. CALLED TO FLOOR TO FIGURE OUT HOW MANY CM MARK AT NOSE USED FOR DOCUMENTATION. UPON ASSESSING TUBE, NO CLEAR MARKINGS, JUST INTERMITTANT WIDE DASHES. OPENED ANOTHER PACKAGE AND USED MEASURING TAPE TO TRY AND FIGURE OUT. WORRIED ABOUT PATIENT AND ASPIRATION. ALSO, WHEN LOOKING AT PACKAGING ON THE 18-GAUGE NASOGASTRIC TUBES, NOTED MARKS WERE IN INCHES AND NOT CENTIMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606923 ↗
• MalfunctionJan 3, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT NASOGASTRIC TUBING TIP WAS MISSING REQUIRED HOLES TO RECEIVE FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438207 ↗
• MalfunctionOct 31, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH WHAT THE CUSTOMER BELIEVE WAS A DEFECT IN A SPECIFIC LOT OF 18G NG TUBES. DOCTOR WAS CALLED IN EARLY THIS MORNING BY THEIR STAFF DUE TO 3 DIFFERENT NASOGASTRIC TUBES LEAKING STOMACH BILE ALL OVER A PATIENT AND CAREGIVERS. THEY HAVE PULLED EVERYTHING WITH THE LOT #NGHT2136 AND THERE WERE VISIBLY BLEMISHES IN THE BLUE TUBING CLOSE TO ITS CONNECTION TO THE CLEAR TUBE. THEY STILL HAVE THE DEFECTIVE TUBE. PLEASE NOTE IT DOES HAVE STOMACH BILE FROM THE PATIENT IN IT AND ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038308 ↗
• MalfunctionOct 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH WHAT THE CUSTOMER BELIEVE WAS A DEFECT IN A SPECIFIC LOT OF 18G NG TUBES. DOCTOR WAS CALLED IN EARLY THIS MORNING BY THEIR STAFF DUE TO 3 DIFFERENT NASOGASTRIC TUBES LEAKING STOMACH BILE ALL OVER A PATIENT AND CAREGIVERS. THEY HAVE PULLED EVERYTHING WITH THE LOT #NGHT2136 AND THERE WERE VISIBLY BLEMISHES IN THE BLUE TUBING CLOSE TO ITS CONNECTION TO THE CLEAR TUBE. THEY STILL HAVE THE DEFECTIVE TUBE. PLEASE NOTE IT DOES HAVE STOMACH BILE FROM THE PATIENT IN IT AND ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038071 ↗
• MalfunctionJun 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT NASOGASTRIC TUBE HAD A HOLE IN IT AND WAS NOT ALLOWING PROPER SUCTION. BASICALLY, IT WAS THE OVAL OPENING THE BLUE TUBE CAME OUT OF. NURSE SAID A DOCTOR TAPED IT UP AND IT BEGAN WORKING PROPERLY. SO, THEY FELT THIS GAP SHOULD BE SEALED OFF RATHER THAN BEING LEFT OPEN. NURSE FELT THEY LIKELY HAVE AN EDUCATIONAL OPPORTUNITY AND NEED TO GET THAT ADDRESSED. THEY LOOKED AT A COMPETITIVE NASOGASTRIC TUBE AND IT HAD A VERY SIMILAR DESIGN, THEREFORE THEY FELT IT MAY BE SOME KIND OF MISUNDERSTANDING ON THE USER'S PART. PER FOLLOW-UP VIA EMAIL ON 05JUN2023, CUSTOMER STATED IN ORDER TO GET THE PRODUCT TO FUNCTION, THEY HAD TO WRAP TAPE AROUND THE AREA OF COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153890 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEW OF THE PATIENTS HAD HOSPITAL ACQUIRED PRESSURE INJURY OVER THE PAST FEW WEEKS TO MONTH AND THEY WANTED TO CHECK IF THESE ITEMS HAD A CHANGE WHEN THEY WERE BEING MANUFACTURED. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16894362 ↗
• MalfunctionMar 3, 2022Unclear Information; Unclear Information

  IT WAS REPORTED THAT THE NASOGASTRIC TUBES DID NOT HAVE NUMBERS ON THEM AND THEREFORE COULD NOT BE ACCURATELY MEASURED AND COMMUNICATED TO THE NEXT CARE PROVIDER WITH CERTAINTY. NASOGASTRIC TUBE WAS ADVANCED MORE AND CONFIRMED WITH AIR BLOW, BUT STILL THERE WAS NO NUMBERS ON THE NASOGASTRIC TUBE TO CONFIRM PLACEMENT WHILE PATIENT WAS IN THE HOSPITAL. THE PATIENT WENT FOR X-RAY TO CONFIRM PLACEMENT AND NASOGASTRIC TUBES WAS NOT IN CORRECT SPOT BY OVER 10CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660895 ↗
• 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 12289921 ↗
• 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 12288990 ↗