Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046160Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00801741052323), received between Aug 31, 2017 and Jun 22, 2026 — classified as 3 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (10 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE NASOGASTRIC TUBE WITH FILTER, 14 FRENCH THAT THIS WAS THE SECOND OG TUBE THAT THEY HAVE FOUND THAT HAS A LEAK AT THE POINT WHERE THE AIR VENT TUBING MEETS THE OG TUBING. WHEN PUSHING OR FLUSHING MEDICATION OR FLUIDS SOME OF THE LIQUID COMES OUT BETWEEN THE JUNCTION OF THE TWO TUBES. THAT MEANS THE PATIENT MAY NOT GET ALL THE SOLUTION AND MEDICATIONS THAT WERE BEING PUSHED THROUGH THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580608 ↗
• MalfunctionApr 22, 2026Component Misassembled

  IT WAS REPORTED THAT THE TEAM HAD A PATIENT WITH AN NG TUBE THAT WAS NOT SUCTIONING WELL. THE TEAM HAD NOTICED THAT THE VENTING HOLES WERE DIFFERENT ON SOME OF THE NG TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958413 ↗
• MalfunctionApr 15, 2026Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAS SEVERAL NG TUBES THAT ARE DEFECTIVE AND HAVE LEAKS. IT HAS CAUSED A PATIENT CARE CONCERN BECAUSE WE ARE HAVING TO REPEATEDLY REPLACE NG TUBES IN PATIENTS. CUSTOMER HAS A SAMPLE OF THE PRODUCT TO SEND IN IF NEEDED. THIS HAPPENED ABOUT A MONTH AGO IN A DIFFERENT DEPARTMENT AS WELL, BUT CUSTOMER DOES NOT HAVE A LOT NUMBER OR A PRODUCT SAMPLE AT THE TIME. ATTACHED THE PHOTO OF THE INCONSISTENT HOLE PLACEMENT. THAT IS WHERE THE LEAK SEEMS TO BE COMING FROM IN EVERY DEFECTIVE NG TUBE CUSTOMER HAVE COME ACROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888883 ↗
• MalfunctionApr 14, 2026Component Misassembled

  IT WAS REPORTED THAT THEY FORWARDED OVER AN ISSUE WITH NASOGASTRIC TUBE AND OPENINGS NOT BEEN PRESENT WHERE THEY SHOULD BE. THEY DID NOT REPLY BACK RIGHT AWAY. THEY TRIED TO OBTAIN SOME BETTER PICTURES FROM SUPPLY CHAIN FOR THEIR QUALITY TEAM. THEY KNEW THEY DID NOT WANT TO REMOVE THAT FROM THE BAG AS THAT WAS IN A PATIENT STOMACH, WELL AT LEAST THEY THOUGHT THEY WERE. NEVERTHELESS, THAT SHOULD BE BACK IN THE BIOHAZARD BAG READY FOR THE BOX THEY WOULD RECEIVE. PER ADDITIONAL INFORMATION RECEIVED ON 10APR2026, IT WAS REPORTED THE UNIT WAS USED ON A PATIENT. CUSTOMER HAD 5 SAMPLES FROM LOT NGKY3113, ONLY 1 HAD THE DEFECT REPORTED. CUSTOMER IS REQUESTING CLOSURE LETTER ONCE THE SAMPLE HAS BEEN EVALUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879600 ↗
• MalfunctionApr 14, 2026Decrease in Suction; Component Misassembled

  IT WAS REPORTED THAT THE TEAM HAD A PATIENT WITH AN NG TUBE THAT WAS NOT SUCTIONING WELL. THE TEAM HAD NOTICED THAT THE VENTING HOLES WERE DIFFERENT ON SOME OF THE NG TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877972 ↗
• MalfunctionApr 11, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT HAS NG TUBE PLACED. CONNECTOR BETWEEN NG TUBE AND SUCTION DOES NOT STAY IN PLACE. UNFORTUNATELY, MULTIPLE EPISODES OF NG TUBE DISCONNECTING FROM SUCTION THROUGHOUT THE NIGHT AND MORNING CAUSING GASTRIC CONTENTS TO SPILL ON PATIENT OR IMPROPER SUCTION FOR PERIODS OF TIME. DUE TO MALFUNCTIONING DEVICE, IT REQUIRES STAFF TO USE TAPE TO KEEP CONNECTOR IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851003 ↗
• MalfunctionOct 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THEY HAD A NASOGASTRIC TUBE, THEY THOUGHT IT WAS MANUFACTURED WITH A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209595 ↗
• MalfunctionAug 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STRAY HAIR FOUND IN THE PEEL POUCH OF SPECIALTY TUBE. AS PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 28OCT2025, IT WAS REPORTED THAT CUSTOMER NO LONGER CARRIES THE IMPACTED PHYSICAL PRODUCT DUE TO THE LAG TIME FROM REPORT TO RESPONSE. PHOTO SAMPLE PROVIDED. LOT NGKR1152 WAS PROVIDED. THE PRODUCT WAS NOT USED ON A PATIENT, AND THE CLINICAL TEAM NOTICED IT PRIOR TO USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874288 ↗
• MalfunctionJun 16, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PRODUCT DID NOT CONNECT PROPERLY TO SUCTION TUBING. THE PLASTIC CONNECTING PIECE DID NOT FIT AND THE SUCTION TUBING DID NOT STAY ATTACHED TO THE NASOGASTRIC TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212236 ↗
• MalfunctionMay 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DOCTOR WAS PLACING AN NASOGASTRIC TUBE IN THE PATIENT AND GOT IT INTO THE CORRECT POSITION WHEN THEY REALIZED THAT IT WAS NOT SUCTIONING PROPERLY. THE DOCTOR CHECKED THE TUBING AND REALIZED IT WAS DEFECTIVE AND HAD AN AIR LEAK. WE HAD TO TAKE OUT THE NASOGASTRIC TUBE THAT WAS JUST PLACED AND REPLACE IT WITH A NEW ONE. IT DID NOT CAUSE HARM TO THE PATIENT, BUT DELAYED CARE AND MADE IT HARD FOR THE PATIENT BECAUSE THEY HAD TO HAVE THE PROCESS DONE TWICE WHICH CAUSED PATIENT A LOT OF ANXIETY.

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

  MAUDE report 22069426 ↗
• MalfunctionMar 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIMARY RN PLACED NASOGASTRIC TUBE (BARD NASOGASTRIC SUMP TUBE ORDER NUMBER (B)(4)) LOT NUMBER NGJW3715, 16 FRENCH. THE NASOGASTRIC TUBE WOULD NOT WORK WHEN CONNECTED TO SUCTION. PRIMARY RN CALLED CN AND CN INSPECTED TUBE. MANUFACTURE MALFUNCTION TO TUBE AT THE BASE OF THE FLUID REFLUX TUBE. CN ASKED PATIENT IF WE COULD PLACE ANOTHER TUBE AND PATIENT DID NOT WANT ANOTHER TUBE PLACED. CN EXPLAINED SITUATION AND PATIENT STILL DID NOT WANT ANOTHER TUBE PLACED. CN CUT TUBE PROXIMAL TO MALFUNCTION TO OBTAIN PATENT SUCTION. THE NASOGASTRIC TUBE HAD A HOLE AT THE BASE OF THE BACKFLOW VALVE. THIS DID NOT ALLOW SUCTION DUE TO IT BEING AN OPEN AND NOT CLOSED SYSTEM. TO QUICKLY PROVIDE PAIN RELIEF BY DECOMPRESSING THE STOMACH IT WAS DETERMINED TO CUT THE TUBE PROXIMAL TO THE MANUFACTURE DEFECT TO CREATE A CLOSED SUCTION SYSTEM. THE PARTIAL TUBE (DISTAL END) IS AT THE CN STATION IN A BIOHAZARD BAG. THIS PORTION OF THE TUBE HAS THE DEFECT. AS A SIDE NOTE, THE NASOGASTRIC TUBE WAS REPLACED ABOUT 45 MIN LATER TO A NEW TUBE AND THERE WERE NO ISSUES WITH THE NEW NASOGASTRIC TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730686 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT 3 ATTEMPTS AT NASOGASTRIC TUBE PLACEMENT WITHOUT AIR CONFIRMATION. DISCOVERED HOLE IN TUBING WHERE AIR VENT MET MAIN LUMEN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697623 ↗
• 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 20926193 ↗
• MalfunctionJul 25, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE CENTIMETERS WERE NOT LABELED ON THE NASOGASTRIC TUBE, PREVENTING NURSES FROM CONFIRMING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827009 ↗
• MalfunctionMay 28, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT NASOGASTRIC TUBE DID NOT HAVE VISIBLE NUMBERS. NURSES WERE REQUIRED TO CHART THE LENGTH OF THE TUBE PLACED AND EXCHANGE THIS INFORMATION IN REPORT. THEY WERE UNABLE TO DO THIS WITH THIS PRODUCT. STAFF WAS UNABLE TO VISUALLY TELL HOW FAR THE TUBE HAS BEEN INSERTED. PER CUSTOMER FOLLOW UP RECEIVED ON 22MAY2024, THE PRODUCT WAS STILL BEING INTERMITTENTLY STOCKED ON THEIR SHELVES- ALL THE NURSES HAVE BEEN ALERTED NOT TO USE THEM AND USE ONLY THE ONES WITH THE NUMBERS ON THEM SO THEY COULD DOCUMENT THE LENGTH EACH SHIFT AND PROVIDE IT IN HAND OFF. OTHERWISE, THERE WAS NO WAY TO CLEARLY TELL IF THE TUBE WAS IN THE CORRECT PLACE PRIOR TO USE. AS PER THE PHOTO SAMPLE, THE COVIDIEN HAS VISIBLE NUMBERS THE BARD PRODUCT DOES NOT, IT ONLY HAS BLACK MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19407403 ↗
• MalfunctionMar 29, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER HAD THE NASOGASTRIC TUBE SAMPLE AND THERE WAS A HAIR IN THE STERILE POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003110 ↗
• MalfunctionSep 7, 2023Unclear Information; Unclear Information

  IT WAS REPORTED THAT NASOGASTRIC TUBES FROM BARD WAS MISSING MEASUREMENTS. THEY WERE HAVING PROBLEMS BECAUSE THEY CANNOT DOCUMENT FOR INSERTION AND EACH SHIFT AS REQUIRED PER THEIR SOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699344 ↗
• InjuryOct 20, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE NASOGASTRIC TUBE BROKE OFF WHEN THEY WERE PULLING IT FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15638010 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER HAD INSERTED AN OROGASTRIC TUBE (OG) AS PER POLICY AND ONCE PLACED AND SECURED, THEY HAD FLUSHED IT WITH WATER. BUT LARGE AMOUNT OF WATER WAS LEAKING FROM ANTI REFLUX BLUE TUBING INSERTION SITE. THE TUBE WAS BACKING UP CAUSING LEAKAGE OF LARGE AMOUNTS OF GASTRIC CONTENTS DESPITE BEING CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315792 ↗
• MalfunctionApr 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE KEPT LEAKING AT THE SUCTION HOSE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193988 ↗
• MalfunctionAug 16, 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 DEFECT CATALOG NUMBER WERE 0046140, 0046160 AND 0046180.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328646 ↗
• 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 12289916 ↗
• MalfunctionApr 20, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE PUNCTURED THE ESOPHAGUS OF THE PATIENT WHEN PLACED. PER ADDITIONAL INFORMATION VIA MAIL ON 23MAR2021, IT WAS MENTIONED THAT THE NASOGASTRIC TUBE CAUSED ESOPHAGEAL BLEEDING AND IT WAS THE FIRST TIME USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11695425 ↗
• MalfunctionApr 20, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE CAUSED THE ESOPHAGEAL BLEEDING TO THE PATIENT. THE PATIENT USED THE DEVICE FOR THE FIRST TIME. ALSO STATED THAT THE USER WAS LOOKING FOR A SOFTER SUBSTRATE THAN PVC AND BELIEVED THAT IT WAS TOO ROUGH. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11695302 ↗
• MalfunctionApr 20, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE NASOGASTRIC TUBE PUNCTURED THE ESOPHAGUS OF THE PATIENT WHEN PLACED. PER ADDITIONAL INFORMATION VIA MAIL ON 23MAR2021, IT WAS MENTIONED THAT THE NASOGASTRIC TUBE CAUSED ESOPHAGEAL BLEEDING AND IT WAS THE FIRST USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11695301 ↗