Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber and Strap 802002Recalls & reported problems
C. R. Bard, Inc. · Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber and Flexible Strap · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741040757), received between May 15, 2018 and Jul 15, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (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
- Restricted Flow rate2
- No Flow1
- Partial Blockage1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE DRAIN BAG HAD A PLASTIC THAT BLOCKED THE URINE FROM ENTERING INTO THE DRAIN BAG, WHICH CAUSED THE BAG TO LEAK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10279892 ↗MalfunctionMay 14, 2019Restricted Flow rate
IT WAS REPORTED THAT THE BAG HAD A VAPOR LOCK RESTRICTING FLOW.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8608496 ↗MalfunctionMay 15, 2018Restricted Flow rate; Restricted Flow rate; No Flow
IT WAS REPORTED THAT URINE STOPPED FLOWING INTO THE DRAIN BAG WHEN THE BAG WAS PARTIALLY FULL. THE PATIENT REPORTED THAT THE URINE BACKED UP WITHIN THE TUBING.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7516430 ↗
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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