Bard® Closed System Urinary Drainage Bag N153509Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801741046770), received between Apr 16, 2020 and Nov 9, 2021 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (9 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
- Deformation Due to Compressive Stress9
- Material Deformation3
- Material Twisted/Bent2
Patient problems
- No Patient Involvement8
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DRAIN BAG TUBE WAS KINKED AND IT PREVENTED FROM BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12779743 ↗MalfunctionAug 13, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINK IN THE TUBING WHICH MADE IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10405143 ↗MalfunctionAug 13, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING WHICH MADE IT UNUSABLE.
Patient problems: No Patient Involvement
MAUDE report 10405045 ↗MalfunctionAug 13, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING WHICH MADE IT UNUSABLE.
Patient problems: No Patient Involvement
MAUDE report 10404718 ↗MalfunctionAug 13, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINK IN THE TUBING WHICH MADE IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10403603 ↗MalfunctionAug 13, 2020Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING WHICH MADE IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10403366 ↗MalfunctionJun 5, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING MAKING IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10122247 ↗MalfunctionApr 17, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING MAKING IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9975443 ↗MalfunctionApr 16, 2020Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE DRAIN BAG HAD EXTREME KINKING IN THE TUBING MAKING IT UNUSABLE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9966917 ↗
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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