Bard® Closed System Urinary Drainage Bag N153504Recalls & reported problems
C. R. Bard, Inc. · Bard® Closed System Urinary Drainage Bag · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801741046763), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Partial Blockage” (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
Device problems
- Partial Blockage1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED, THAT THE PATIENT ARRIVED TO POST ANESTHESIA CARE UNIT (PACU). FROM OPERATING ROOM, AFTER HERNIA REPAIR SURGERY. IN WHICH, PATIENT RECEIVED 3 LITERS OF IV FLUID. A FOLEY URINARY CATHETER WAS PLACED IN THE OPERATING ROOM. UPON ARRIVAL TO THE POST ANESTHESIA CARE UNIT (PACU), THE SURGEON NOTICED, THE FOLEY WAS NOT DRAINING URINE. ON CLOSER INSPECTION, IT WAS DISCOVERED, THE FOLEY TUBING HAD A MANUFACTURE DEFECT. AND WAS OCCLUDED BY A PIECE OF PLASTIC PREVENTING URINE FROM DRAINING INTO FOLEY BAG. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2020 FROM THE COMPLAINANT, THE FOLEY CATHETER ITSELF WAS FUNCTIONING. THE TUBING TO THE BAG ITSELF HAD SOME KIND OF BLOCKAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10681978 ↗
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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