Bard® Urinary Drainage Bag With Anti-Reflux Dome 154003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741040771), received between Jun 25, 2019 and Dec 11, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Backflow” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER BALLOON WAS DIFFICULT TO DEFLATE AND REMOVE. 8 ML WAS REMOVED AND NO FURTHER FLUID COULD BE REMOVED. THE CATHETER APPEARED TO BE SUCTIONING IN ON ITSELF. AS THE TUBING WAS BEING PULLED FROM THE PATIENT, SOME MILD RESISTANCE WAS MET. ANOTHER ATTEMPT TO REMOVE FLUID WAS UNSUCCESSFUL. THE PATIENT COMPLAINED OF DISCOMFORT AS THE CATHETER WAS PULLED OUT. ONCE REMOVED, IT WAS NOTED THAT THE BALLOON WAS STILL INFLATED TO APPROXIMATELY THE SIZE OF A MARBLE. THE REMAINING FLUID/AIR IN THE BALLOON COULD NOT BE REMOVED.

  Patient problems: Discomfort

  MAUDE report 10992693 ↗
• InjuryAug 24, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT PATIENT GOT A URINARY TRACT INFECTION HAD BEEN TREATED WITH MEDICATION. NO OTHER INFORMATION GIVEN. IT WAS UNKNOWN IF THE LEG BAG CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10445729 ↗
• MalfunctionJun 9, 2020Partial Blockage; Partial Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AND A BLOCKAGE DUE TO THE USAGE OF REPLACED CATHETER SUPPLIES AND PATIENT WENT THROUGH BAGS QUICKER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10134834 ↗
• MalfunctionJul 30, 2019Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEG BAG WAS IN GENERAL "DEFECTIVE" AND THE PATIENT WASN'T ABLE TO USE IT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842565 ↗
• MalfunctionJul 9, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE DRAIN BAG TUBING BECAME KINKED AT NIGHT.

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

  MAUDE report 8773033 ↗
• MalfunctionJun 25, 2019Restricted Flow rate; Backflow; Restricted Flow rate

  IT WAS REPORTED THAT URINE WAS BACK FLOWING FROM THE DRAIN BAG INTO THE CATHETER AT TIMES EVEN WHEN THE BAG WAS BEING EMPTIED.

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

  MAUDE report 8732731 ↗