Bard® PreVent® Anti-Reflux Filter 0046000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741052286), received between Mar 1, 2019 and May 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024

  A SALEM SUMP NASOGASTRIC TUBE WAS PLACED FOR DECOMPRESSION. THE BARD PREVENT ANTI-REFLUX FILTER WAS PLACED UPSIDE DOWN IN THE AIR VENT. THE TUBE WAS NOT DECOMPRESSING PATIENT'S STOMACH, AND PATIENT WAS ABLE TO VOMIT AROUND TUBE. DURING NURSING PEER REVIEW, IT WAS IDENTIFIED THE PRODUCT'S INSTRUCTIONS ARE NOT CLEAR ON WAY TO INSERT. THE INSTRUCTIONS STATE "FIRMLY SEAT TAPERED END OF ANTI-REFLUX FILTER IN BLUE AIR LUMEN VENT OF NG TUBE." THE REGISTERED NURSES (RNS) INVOLVED AND OTHER RNS ASKED ABOUT THE PLACEMENT OF FILTER FELT THE PACKAGE INSTRUCTIONS LEFT TOO ROOM FOR INTERPRETATION AND IT WAS NOT CLEAR. THE RNS WOULD LIKE MORE DESCRIPTION OF INSERTION BLUE END INTO THE BLUE AIR VENT OR AN ARROW TO SHOW DIRECTION FOR INSERTION. CURRENTLY THE DEVICE HAS A LABEL STATING INFUSE AIR ONLY.

  Patient problems: Gastrointestinal Regurgitation; Vomiting

  MAUDE report 19319890 ↗
• MalfunctionMar 2, 2019Degraded; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

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

  MAUDE report 8384423 ↗
• MalfunctionMar 2, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

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

  MAUDE report 8384361 ↗
• MalfunctionMar 2, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MARKINGS ON THE NG TUBE HAD RUBBED OFF. WITHOUT THE MARKINGS, THE NURSING STAFF COULD NOT DETERMINE WHERE THE NG TUBE WAS INSERTED, OR WHERE IT SHOULD BE LOCATED. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

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

  MAUDE report 8384358 ↗
• MalfunctionMar 1, 2019Device Markings/Labelling Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MARKINGS ON THE NGT RUBBED OFF AND WITHOUT THE MARKINGS THE NURSING STAFF COULD NOT DETERMINE WHERE THE NGT WAS INSERTED OR ITS LOCATION. ADDITIONALLY, IT WAS ALLEGED THAT RESIDUE REMAINED IN THE FILTERS AFTER USE.

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

  MAUDE report 8384097 ↗