Bard® Urinary Drainage Bag with Anti-Reflux Chamber N154002Recalls & reported problems
C. R. Bard, Inc. · Bard® Urinary Drainage Bag with Anti-Reflux Chamber · Class 2
All models of Bard Urinary Drainage Bag with Anti-Reflux Chamber (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741046787), received between Feb 7, 2021 and Jul 26, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (2 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
Device problems
- Component Misassembled2
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2023Component Misassembled; Component Misassembled
IT WAS REPORTED THAT FAULTY FOLEY TRAY IN THE ABD HYSTERECTOMY PACK. THE SAMPLE PORT WAS MISSING FROM THE FOLEY BAG. THIS LED TO URINE ALL OVER THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396257 ↗MalfunctionFeb 7, 2021Device Damaged Prior to Receipt by User; Component Misassembled; Device Damaged Prior to Receipt by User; Component Misassembled
IT WAS REPORTED THAT THE FOLEY CATHETER CAME OUT OF THE PACK. IT WAS SEALED SHUT AND NOT ABLE TO EMPTY THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11290516 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER117 reports
- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 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
- 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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