Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ EN0046180Recalls & reported problems
C. R. Bard, Inc. · Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741113260), received between May 24, 2018 and Sep 29, 2022 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (2 reports).
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
- 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-0800-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Suction Problem2
- Failure to Capture1
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
- Insufficient Device Problem Information1
- Occlusion Within Device1
- Partial Blockage1
Patient problems
- No Patient Involvement2
- Abdominal Distention1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
- Pain1
- Swelling1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE NASOGASTRIC TUBE DID NOT DO WHAT INTENDED IN MEDICAL SETTING. THE ISSUE WITH THE NASOGASTRIC TUBE WAS UNKNOWN. THE PRODUCT CATALOG NUMBERS PROVIDED BY CUSTOMER WERE EN0046100, EN0046120, EN0046140, EN0046160 AND EN0046180.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15508671 ↗MalfunctionApr 17, 2019Failure to Capture; Suction Problem; Failure to Capture
IT WAS REPORTED THAT DURING SURGERY, A LARGE AMOUNT OF PARTICULATE MATTER THAT COULD NOT BE SUCTIONED THROUGH THE ENFIT SUCTION ADAPTER; HOWEVER, 2000CC OF GASTRIC FLUID WAS REMOVED FROM THE PATIENT'S STOMACH.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8523078 ↗MalfunctionMar 28, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement
IT WAS REPORTED THAT THE ENFIT LUMEN SIZE ON THE NEW CONNECTOR APPEARED TO BE TOO SMALL AND CAN POTENTIALLY CAUSE CLOGS.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8460900 ↗MalfunctionMay 31, 2018Suction Problem; Suction Problem
IT WAS REPORTED THAT THE NG TUBE DID NOT SUCTION WELL. THE COMPLAINANT REPORTED THAT THE "INNER MOAT" OF THE ENFIT CONNECTOR LIMITED THE SUCTION. THE COMPLAINANT TESTED THE PRODUCT WITHOUT A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7557526 ↗InjuryMay 24, 2018Partial Blockage; Occlusion Within Device; Partial Blockage
IT WAS REPORTED THAT THE NG TUBE CLOGGED WHILE IN USE. THE COMPLAINANT REPORTED THAT THE PATIENT HAD "CHUNKS" IN STOMACH CONTENT THAT WOULD NOT PASS THROUGH THE ENFIT CONNECTOR. THE PATIENT ALLEGEDLY EXPERIENCED ABDOMINAL DISTENSION AND PAIN. THE NURSING STAFF IRRIGATED THE NG TUBE AND AFTER A WHILE ENDED UP GETTING 1400 CC OUT AFTERWARDS, THEN THE PATIENT HAD A 1000CC EMESIS.
Patient problems: Abdominal Distention; Pain; Swelling; Vomiting
MAUDE report 7542270 ↗
Other TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION devices
- Salem Sump 8888266114Cardinal Health 200, LLC · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION2 recalls0 reports
- CARDINAL HEALTH 8888266122ECardinal Health 200, LLC · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall9 reports
- CARDINAL HEALTH 8888266130ECardinal Health 200, LLC · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall7 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™ EN0046160C. R. Bard, Inc. · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall7 reports
- Salem Sump 8888266148Cardinal Health 200, LLC · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall5 reports
- Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter 0046160C. R. Bard, Inc. · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION54 reports
- Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ EN0056140C. R. Bard, Inc. · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall4 reports
- Salem Sump 266148Cardinal Health 200, LLC · TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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