Bard Urinary Drainage Bag with Anti-Reflux ChamberRecalls & reported problems across all models

We found 6 models of Bard Urinary Drainage Bag with Anti-Reflux Chamber by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Aug 11, 2026 — classified as 19 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (82 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard Urinary Drainage Bag with Anti-Reflux Chamber problems

Bard Urinary Drainage Bag with Anti-Reflux Chamber models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  107 reports
• Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154006

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  27 reports
• Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154004

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  12 reports
• Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154102

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  8 reports
• Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154114

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  4 reports
• Bard® Urinary Drainage Bag with Anti-Reflux Chamber N154002

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  2 reports

Recent Bard Urinary Drainage Bag with Anti-Reflux Chamber adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209940 ↗
• InjuryMay 17, 2026Restricted Flow rate; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THE BD URINE DRAINAGE BAG WITH ANTI REFLUX CHAMBER (2000 ML) DID NOT FUNCTION AS INTENDED. ALTHOUGH THE PRODUCT CLAIMED TO HAVE AN ANTI REFLUX CHAMBER, URINE FLOWED BACK INTO THE TUBING. FOR APPROXIMATELY 6 MONTHS TO 1 YEAR, SPECIAL CARE HAD BEEN TAKEN WHILE EMPTYING THE BAG TO PREVENT URINE BACKFLOW; HOWEVER, REFLUX STILL OCCURRED AND WAS REPORTED TO HAVE LED TO URINARY TRACT INFECTIONS IN THE PATIENT¿S SON. IT WAS FURTHER REPORTED THAT IF THE BAG WAS ACCIDENTALLY TURNED OR TILTED, URINE FLOWED BACK INTO THE TUBING. THIS ISSUE HAD NOT OCCURRED PREVIOUSLY AND WAS INCONSISTENT WITH THE PRODUCT¿S STATED ANTI REFLUX FEATURE. THE CUSTOMER EMPHASIZED THAT THE MALFUNCTION COMPROMISED PATIENT SAFETY AND PRODUCT RELIABILITY, AS URINE REFLUX SHOULD NOT OCCUR UNDER NORMAL CONDITIONS OF USE.

  Patient problems: Urinary Tract Infection

  MAUDE report 25196366 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE URINE SAMPLING PORT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460012 ↗
• MalfunctionJan 30, 2026Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER SAID HE RECEIVED PRODUCT FROM LIBERATOR THAT DOESN'T WORK. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228788 ↗
• MalfunctionDec 17, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PT SAID IT DID NOT HAVE ANTI-REFLUX LIKE IT STATES; THE BAGS NOT WORKING. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831637 ↗
• MalfunctionDec 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD DEBRIS IN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811718 ↗
• MalfunctionNov 18, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT, WHEN CUSTOMER WAS INSERTING THE SYRINGE TO RELEASE THE URINE INTO THE DRAIN BAG NOTHING WAS COMING OUT. CUSTOMER HAD QUITE A FEW WITH THIS BATCH NUMBER SO THIS LEFT EXTREMELY SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586257 ↗
• MalfunctionNov 17, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER CALLED TO REPORT THAT THEY USED 154002 DRAIN BAG WHEN PATIENT WAS SLEEPING ON THEIR BACK, NO ISSUES, WHENEVER THEY TURNS TO THEIR LEFT, THERE WAS NO SUCTION AS THE DRAIN STOPPED WORKING UNTIL THEY REACHED UP TO THEIR UROSTOMY POUCH AND ADJUST THEN THE URINE BEGINS FLOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572960 ↗
• MalfunctionNov 7, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE FOLEY CATHETER DRAINING URINE INTO BAG. WHEN REGISTERED NURSE WENT TO EMPTY BAG IT WOULD NOT DRAIN AND SEEMED TO BE OCCLUDED. NO VISUAL OCCLUSION NOTED. CATHETER NEEDED TO BE REPLACED. CUSTOMER STATED THAT THEY HAD BEEN WORKING DIRECTLY WITH A REPRESENTATIVE, SO ANY SAMPLES THAT THEY HAD WOULD BE RETURNED TO THEM. IF AND WHEN ANY ADDITIONAL INFORMATION WAS RECEIVED, THE RECORD WOULD BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497743 ↗
• MalfunctionNov 6, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT UNABLE TO DRAIN 1/2 FULL URINE BAG INTO MEASURABLE CONTAINER. ABLE TO UNCLAMP THE CLAMP, BUT NO URINE DRAINS FROM TUBE. APPEARS TUBE WAS NOT FILLED WITH URINE? POSSIBLE BLOCKAGE AT BOTTOM OF URINE BAG THAT CONNECTS TO THE TUBE THAT WAS CLAMPED. MULTIPLE REGISTERED NURSE ATTEMPTED TO TROUBLE SHOOT PROBLEM. FOLEY HAD TO BE REMOVED AND A NEW ONE PLACED. A UROMETER FOLEY WAS USED DUE TO THE CONCERNS OF THAT LOT # OF FOLEY TRAY SYSTEMS THAT WERE CURRENTLY STOCKED ON THE UNIT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14NOV2025, IT WAS REPORTED THAT THE FOLEY CATHETER HAD TO BE REMOVED BECAUSE IT WOULD NOT DRAIN. A NEW FOLEY CATHETER HAD TO BE PLACED. THEY TROUBLESHOOTING WAS PERFORMED BY SEVERAL NURSES ATTEMPTING TO DRAIN THE DEFECTIVE FOLEY CATHETER. THEY DESCRIBED THE DEFECTIVE FOLEY CATHETER IN MY INITIAL PRODUCT CONCERN. THE CATHETER WOULD NOT DRAIN DESPITE MULTIPLE ATTEMPTS BY SEVERAL NURSES TO DRAIN IT. THERE WAS URINE IN THE BAG, THE CLAMP WAS UNCLAMPED, BUT STILL NO URINE WAS DRAINING FROM THE URINE BAG. A UROMETER WAS PLACED DUE TO THE MULTIPLE FOLEY CATHETER DEFECTS WE WERE EXPERIENCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488460 ↗
• MalfunctionNov 3, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE DRAIN BAGS ARE DEFECTIVE VALVE WILL NOT DRAIN URINE. EXCHANGING DEFECTIVE BAGS. NO BIO BOX NEEDED. AUTHORITY DISCARDED DRAIN BAGS. PREFER ITEM #57154114A. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED.NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453126 ↗
• MalfunctionSep 17, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE GREEN CLAMP ON THE DRAIN BAG WAS FULLY SEALED AND NOT ABLE TO DRAIN THE URINE. THE CATHETER WAS REPLACED WITH A NEW ONE. PATIENT HAD AN UNNEEDED SECONDARY CATHETERIZATION. NO PRODUCT RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073165 ↗
• MalfunctionSep 15, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BARD URINARY BAG DOES NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053261 ↗
• MalfunctionSep 11, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT REGISTERED NURSE REPORTED THAT COMPLAINING THAT FOLEY TUBING SOFTER, BENDING, KINKING MORE OFTEN. THE TUBING ON THEM WAS VERY SOFT INSTEAD OF RIGID, LIKE THE PREVIOUS ONES. SO, THEY WERE ALWAYS GETTING KINKED, AND IT WAS COMMON TO HAVE TO DRAIN THE FOLEY LIFT IT UP TO CREATE A BACK PRESSURE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25SEP2025, A BEDSIDE NURSE NOTICED THESE NOTICEABLE KINKS ON THE DRAINAGE TUBING ON TWO OF THE PATIENTS WHO HAD JUST RETURNED FROM THE O.R. ONE FLOOR NURSE MADE A COMMENT TO STATE HAS NOTICED THAT THE TUBING SEEMS LESS STIFF COMPARED TO BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031507 ↗
• MalfunctionAug 22, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THEY HAD ONE ISSUE ON (B)(6) 2025 WITH THE BAG NOT DRAINING, PRODUCT CONCERN FORM WAS SUBMITTED, AND THE SECOND INCIDENT OF THE BAG NOT DRAINING OCCURRED OVERNIGHT, PRODUCT CONCERN FORM WAS SUBMITTED THAT MORNING. THEY HAD AN ADDITIONAL ISSUE OF A FOLEY BAG LEAKING THEY DID NOT THINK A PRODUCT CONCERN FORM WAS SUBMITTED. THEY TOLD BY LABOR AND DELIVERY THAT WITHIN THE LAST 2 DAYS THEY ALSO ENCOUNTERED A FOLEY BAG THAT WAS NOT DRAINING, THEY DID NOT KNOW IF A CONCERN FORM WAS SUBMITTED. IN LOOKED AT THE LIST OF 17 CONCERNS THERE WERE MANY SIMILAR CONCERNS WITH THE FOLEY BAG OR THE BALLOON LEAKING. THAT ALSO APPEARED THAT THE MAJORITY OF OUR CONCERNS ARE FROM 2 DIFFERENT GROUPS OF FOLEYS IN MULTIPLE SIZES WITHIN THE GROUP. GROUP 1: A947314 FOR SIZE FOR FOLEY BAG (PCN#154002) AND FOR CATHETER (PCN#175814). GROUP 2: A3195¿¿ FOR SIZE FOR DRAIN BAG (PCN#Z10) AND FOR CATHETER (PCN#Z01). LABOR AND DELIVERY PULLED ABOUT 25 OF THE FOLEY TRAYS WITH LOT #NGKP4405 AND THEY HAD PULLED 3 FROM THE MBU STOCK. HRPS AND PRODUCT CONCERN FORM (4616-PC) WERE COMPLETED. THE TWO USED, DEFECTIVE FOLEYS WERE SAVED AND AVAILABLE TO BE PICKED UP. THEY WERE ALL IN KALEYA OFFICE, THEY CAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872113 ↗

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