Bard Nasogastric Sump Tube with PreVent Anti-Reflux FilterRecalls & reported problems across all models
C. R. Bard, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 119
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 6 models of Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 119 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2017 and Jun 22, 2026 — classified as 6 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter problems
Device problems
- Leak/Splash13
- Material Split, Cut or Torn12
- Difficult to Insert11
- Fluid/Blood Leak11
- Material Deformation10
- Break9
- Component Misassembled7
- Deformation Due to Compressive Stress7
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- No Consequences Or Impact To Patient41
- No Known Impact Or Consequence To Patient39
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Hemorrhage/Blood Loss/Bleeding3
- Foreign Body In Patient1
- Injury1
- Internal Organ Perforation1
Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046160TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION54 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046180TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION38 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046140TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION20 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046163TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION3 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046100TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION2 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046120TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION2 reports
Recent Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗MalfunctionDec 3, 2025Unclear Information; Unclear Information
IT WAS REPORTED THAT THE OG OROGASTRIC TUBE WAS STOCKED AS A PRODUCT REPLACEMENT FOR A PRODUCT THAT HAS EXTERNAL MEASUREMENT MARKINGS, THIS TUBE PRODUCT DID NOT. THE OG TUBE WAS PLACED ON REDACTED DATE AND PRESUMABLY MIGRATED POTENTIALLY CONTRIBUTING TO OR CAUSING GASTRIC PERFORATION REQUIRING EMERGENCY ABDOMINAL SURGERY. CHEMOTHERAPY BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708780 ↗InjuryDec 2, 2025Migration; Migration
IT WAS REPORTED THAT THE OG OROGASTRIC TUBE WAS STOCKED AS A PRODUCT REPLACEMENT FOR A PRODUCT THAT HAS EXTERNAL MEASUREMENT MARKINGS, THIS TUBE PRODUCT DID NOT. THE OG TUBE WAS PLACED ON REDACTED DATE AND PRESUMABLY MIGRATED POTENTIALLY CONTRIBUTING TO OR CAUSING GASTRIC PERFORATION REQUIRING EMERGENCY ABDOMINAL SURGERY. CHEMOTHERAPY BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23701210 ↗InjuryNov 20, 2025Use of Device Problem; Device Markings/Labelling Problem; Migration
THIS OG [OROGASTRIC] TUBE WAS STOCKED AS A PRODUCT REPLACEMENT FOR A PRODUCT THAT HAS EXTERNAL MEASUREMENT MARKINGS, THIS PRODUCT DOES NOT. THE OG TUBE WAS PLACED ON [REDACTED DATE] AND PRESUMABLY MIGRATED POTENTIALLY CONTRIBUTING TO OR CAUSING GASTRIC PERFORATION REQUIRING EMERGENCY ABDOMINAL SURGERY.
Patient problems: Internal Organ Perforation
MAUDE report 23605143 ↗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 ↗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 ↗
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- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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