Bard® Urinary Drainage Bag 153504Recalls & reported problems
C. R. Bard, Inc. · Bard® Urinary Drainage Bag · Class 2
All models of Bard Urinary Drainage Bag (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard urinary drainage bag collects urine from an indwelling catheter. The 84 reports mostly describe urine leaking from the bag, tube or connections, as well as restricted flow, kinks, and crushed or bent tubing. There are no deaths and one injury, in which a patient went to the hospital for a leak and had the bag replaced. Reports dropped from 17 to 2 in the past 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 89
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00801741029530), received between Apr 19, 2017 and Jun 11, 2026 — classified as 1 injury, 88 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (27 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.
Reports received per month
Most reported problems
Device problems
- Restricted Flow rate27
- Fluid/Blood Leak18
- Deformation Due to Compressive Stress17
- Material Twisted/Bent11
- No Flow8
- Kinked6
- Material Deformation6
- Obstruction of Flow4
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- No Known Impact Or Consequence To Patient30
- No Consequences Or Impact To Patient24
- No Information7
- No Patient Involvement3
- Patient Problem/Medical Problem2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE THERE WAS URINARY LEAKAGE FROM THE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479054 ↗MalfunctionJun 5, 2026Fluid/Blood Leak
IT WAS REPORTED THAT AN INDIVIDUAL CUSTOMER REPORTED THAT ABOUT A WEEK AFTER FOLEY CATHETER PLACEMENT AT HOME, THEY EXPERIENCED URINE LEAKAGE FROM AROUND THE BASE OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409298 ↗MalfunctionMay 23, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE CONNECTION BETWEEN THE VALVE AND THE TUBE WAS LOOSE, CAUSING URINE TO LEAK OUT. WHEN HEALTH PROFESSIONAL PUSHED THE TUBE FIRMLY INTO THE VALVE, THE LEAK STOPPED. HEALTH PROFESSIONAL HAVE RECEIVED A REQUEST TO INVESTIGATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25265035 ↗MalfunctionMay 16, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING USE AFTER CATHETER INSERTION, URINE WAS LEAKING FROM AN UNIDENTIFIED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196022 ↗MalfunctionApr 13, 2026Fluid/Blood Leak
IT WAS REPORTED THAT URINARY LEAKAGE FROM THE BACK OF THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24863136 ↗InjuryNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THIS WAS A CASE OF URINE LEAKAGE FROM THE URINATION COCK OF THE DRAIN BAG. THE PATIENT CAME TO THE HOSPITAL BECAUSE OF THE LEAK AND HAD IT REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23584798 ↗MalfunctionNov 5, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS URINE LEAKAGE FROM THE JOINT BETWEEN THE BAG AND THE TUBE. THE LEAKAGE WAS CONFIRMED DURING USE IN THE UROLOGY OUTPATIENT CLINIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479504 ↗MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WITHIN ONE WEEK AFTER PLACEMENT, URINE LEAKED FROM THE DRAIN BAG. PER FOLLOW UP INFORMATION RECEIVED ON 29OCT2025, CUSTOMER CONFIRMED THAT URINE WAS LEAKED FROM BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415227 ↗MalfunctionOct 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER OPENING FOREIGN OBJECT FOUND, AS TAPE ATTACHED TO THE DOME OF THE DRAIN BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404562 ↗MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT URINE LEAKED FROM NEAR THE FOLEY CATHETER CONNECTION. LOCATION UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097172 ↗MalfunctionSep 19, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE TUBE OF THE URINE COLLECTION DRAIN BAG WAS DEFORMED UPON OPENING, AND IT WAS REFRAINED FROM USING IT. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 08SEP2025, STATED THERE WAS A SLIGHT KINK IN THE INLET TUBE OF THE URINE COLLECTION BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095131 ↗MalfunctionAug 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A DOCTOR INSERTED A BALLOON TO COLLECT URINE AND MANAGE URINATION. WHEN THE NEEDLE SAMPLE PORT WAS DISINFECTED WITH AN ALCOHOL SWAB AND THE URINE SYRINGE WAS INSERTED IN THE DRAIN BAG, THE PLASTIC OF THE SAMPLE PORT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860920 ↗MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT IT SEEMS THAT THERE WAS LEAKAGE AFTER USE. THE EXACT LOCATION OF THE URINE LEAKAGE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394998 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE URINE LEAKED NEAR THE SAMPLING PORT. URINE LEAKED WAS DISCOVERED FROM THE SIDE OF THE SAMPLING PORT IN THE EMERGENCY WARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069841 ↗MalfunctionMar 14, 2025Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT IT WAS DIFFICULT TO DRAIN URINE FROM THE ROUND BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605289 ↗MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING PLACEMENT, WATER LEAKED FROM THE CONNECTION BETWEEN THE FOLEY CATHETER AND INLET TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374212 ↗MalfunctionFeb 7, 2025Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, THE CONNECTION BETWEEN THE RUNNING BAG AND THE CATHETER WAS DAMAGED AND THE CATHETER COMES OFF DUE TO BREAKAGE OF THE RUNNING TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332650 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT URINE LEAKED FROM THE BASE OF THE URINARY DRAINAGE OPENING, SOON AFTER THE IMPLANTATION. WHEN USING OTHER PRODUCTS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 08JAN2025, CUSTOMER STATED THAT URINE LEAKED FROM THE BASE OF THE URINARY DRAINAGE OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21197225 ↗MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT WHO WENT HOME HAD A URINE LEAK ABOUT 10 HOURS AFTER BEING INSERTED IN THE EMERGENCY ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036558 ↗MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DRAIN BAG LEAKED ABOUT 10 DAYS AFTER RETURNING HOME AFTER INSERTION IN THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21026682 ↗MalfunctionDec 20, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT A FEW HOURS AFTER USE ONLY 300 ML OF URINE WAS COLLECTED IN THE URO DRAIN BAG, AND NO MORE THAN THAT FLOWS TOWARD THE BAG AND WAS COUNTER-FLUSHED. LOT# MYHW3361, LOT# MYHW3359, LOT# MYHW1640.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20988380 ↗MalfunctionDec 20, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT A FEW HOURS AFTER USE ONLY 300 ML OF URINE WAS COLLECTED IN THE URO DRAIN BAG, AND NO MORE THAN THAT FLOWS TOWARD THE BAG AND WAS COUNTER-FLUSHED. LOT# MYHW3361, LOT# MYHW3359 , LOT# MYHW1640 .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20988378 ↗MalfunctionDec 20, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT A FEW HOURS AFTER USE ONLY 300 ML OF URINE WAS COLLECTED IN THE URO DRAIN BAG, AND NO MORE THAN THAT FLOWS TOWARD THE BAG AND WAS COUNTER-FLUSHED. LOT# MYHW3361, LOT# MYHW3359 , LOT# MYHW1640 ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20986670 ↗MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT MOVED TO THE WARD AFTER THE OPERATION. IN THE WARD, URINE LEAKAGE WAS CONFIRMED. IT WAS ALSO FOUND THAT THE FOLEY CATHETER LEAKED DURING THE TRANSFER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20797503 ↗MalfunctionAug 8, 2024Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW WHY URINE WAS NOT FLOWING EASILY IN DRAIN BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19941909 ↗
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
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
- Medline DYND12578Medline Industries, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall10 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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