Bard® Urine Meter with Bag 153202Recalls & reported problems
C. R. Bard, Inc. · Bard® Urine Meter with Bag · Class 2
All models of Bard Urine Meter with Bag (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741033100), received between Apr 28, 2017 and Apr 8, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Deformation Due to Compressive Stress1
- Device Contamination with Chemical or Other Material1
- Partial Blockage1
- Restricted Flow rate1
Patient problems
- Abdominal Pain1
- Discomfort1
- Incontinence1
- Muscle Spasm(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Patient Problem/Medical Problem1
- Urinary Retention1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT A CUSTOMER WAS EXPERIENCING ISSUES WITH THE URINE METER DRAIN BAG TUBING KINKING. THE TUBING WAS KINKING AT THE POINT WHERE IT CONNECTED TO THE METER. THIS ISSUE HAD NOT BEEN PERSONALLY ENCOUNTERED PREVIOUSLY; HOWEVER, IT WAS ALSO ACKNOWLEDGED THAT NOT ALL COMPLAINTS ARE REPORTED DIRECTLY. IT WAS SUGGESTED THAT THE CUSTOMER CHECK HOW THE BAGS WERE BEING STORED TO ENSURE THAT STORAGE CONDITIONS WERE NOT CREATING A ¿MEMORY¿ IN THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24823520 ↗MalfunctionNov 5, 2020Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THERE WAS AN ALLEGED PLUG INSIDE THE TUBING THAT WAS PREVENTING URINE FROM FLOWING INTO THE URINE COLLECTION BAG. THE PATIENT HAD A LOT OF SPASMS AND WAS UNCOMFORTABLE.
Patient problems: Discomfort; Muscle Spasm(s)
MAUDE report 10795661 ↗InjurySep 18, 2019Restricted Flow rate; Adverse Event Without Identified Device or Use Problem; Restricted Flow rate
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED ABDOMINAL PAIN WITH FULL BLADDER SENSATION DUE TO NO URINE FLOW. THE PATIENT WAS PROBED IN THE INTENSIVE CARE UNIT. URINE WOULD NOT FLOW, JUST DRIP. A CONTROL BLADDER SCAN WAS PERFORMED ON THE PATIENT AND 900 CC WAS FOUND IN THE PATIENT'S BLADDER.
Patient problems: Abdominal Pain; Incontinence; Patient Problem/Medical Problem; Urinary Retention
MAUDE report 9082863 ↗MalfunctionApr 28, 2017Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A STAIN ON THE CONNECTOR OF THE DRAINAGE BAG. THE INCIDENT WAS FOUND PRIOR TO USE. THERE WAS A TRANSPARENT MATERIAL INSIDE OF THE EZ-LOK CONNECTOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6531068 ↗
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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