Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00801741040740), received between May 11, 2017 and Nov 1, 2023 — classified as 29 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (50 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

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DRAIN BAG WAS NOT WORKING PROPERLY, THE URINE WAS NOT GETTING INTO THE BAG. PER CUSTOMER FOLLOW UP ON (B)(6) 2023, IT WAS REPORTED THAT THE CUSTOMER HAD THE INCORRECT SIZE OF 25MM AND NEEDS 21MM. CUSTOMER ALSO STATED THE PATIENT WAS HAVING DIFFICULTY USING THE PRODUCT AND CUSTOMER DOES NOT UNDERSTAND THE DIRECTIONS. CUSTOMER WAS ADVISED TO CONTACT LIBERATOR TO INQUIRE ABOUT GETTING THE CORRECT SIZE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046451 ↗
• MalfunctionJul 17, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TUBING CONNECTOR ON THE END THAT CONNECTS TO THE NIGHTTIME DRAIN BAG WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336643 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DRAIN BAG LEAKED OUT WHERE THE TUBE CONNECTED TO THE BAG. NO ADDITIONAL INJURY OCCURRED DUE TO MALFUNCTION. CHANGED BAG ONCE A MONTH. PER FOLLOW UP VIA PHONE ON 12JUN2023, IT WAS REPORTED THAT TWO BAGS LEAKED AFTER USING EACH FOR ONLY ONE DAY. THE CUSTOMER WAS CURRENTLY DEALING WITH A BLADDER INFECTION AND WAS PRESCRIBED PYRIDIUM TO HELP ALLEVIATE THE URINARY TRACT INFECTION. THE ANTIBIOTIC HAD CAUSED THE URINE TO SMELL TOO STRONG, AND THE BAGS WERE DISPOSED OF AFTER THEY LEAKED. PER FOLLOW UP VIA PHONE ON 11AUG2023, IT WAS REPORTED THAT CUSTOMER WAS IN NEED OF REPLACEMENT UNITS FOR THE DRAIN BAGS THEY DISPOSED BACK IN JUNE. THE CUSTOMER WAS ADVISED TO GO THROUGH THEIR CURRENT PRODUCT SUPPLIER, TRI-STATE SUPPLIES, LLC IN LINCOLN, NEBRASKA. CUSTOMER WOULD COORDINATE WITH THEM TO RECEIVE REPLACEMENT UNITS.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17218480 ↗
• MalfunctionJun 27, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BLADDER WOULD NOT DRAIN WHILE DRAIN BAG CONNECTED TO FOLEY. THE REPRESENTATIVE HAD THE PATIENT TO CHECK DRAIN BAG TUBING FOR KINKS AND RECOMMENDED HANGING BAG LOWER THAN BODY AND ALSO TO CHECK FOR CATHETER FOR BLOCKAGE. AS PER ADDITIONAL INFORMATION RECEIVED FROM LIBERATOR ON 13JUN2023, WHEN THE PATIENT WAS USING DRAIN BAG URINE WAS NOT RELEASING FROM BODY AND PATIENT EXPERIENCE BURNING AND WHEN THE PATIENT SWAPS TO LEG BAG, AND WAS ABLE TO RELEASE URINE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Burning Sensation

  MAUDE report 17208189 ↗
• MalfunctionJun 15, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE DRAIN BAG WAS NOT ABLE TO DRAIN, PLASTIC WAS SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135738 ↗
• MalfunctionJun 9, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DOES NOT FLOW INTO THE BAG FROM THE CATHETER. REPRESENTATIVE ADVISED THEM THAT THE BAG MUST HAVE A LITTLE BIT OF AIR TO ALLOW THE URINE TO FLOW INSIDE OF THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098155 ↗
• MalfunctionJun 6, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER BROUGHT THE DRAIN BAG FOR NIGHT TIME SLEEP; THEY PUT A CATHETER IN THEIR PENIS AND WOULD HOOK THE BARD CLOSE SYSTEM DRAIN BAG TO THE DEVICE. ALL THE CORRECT INSTRUCTIONS GOT THE DRAIN CLOSED, AND THERE WAS A VERY SUPERIOR CONNECTION FROM THE MALE CATHETER TO THE BAG. PUT THE BAG WITH THE HANGING CLAMP ON THE SIDE OF THE BAG ON THE RAILING AT THE BOTTOM AND TRIED TO GO TO SLEEP ON THEIR LEFT SIDE AND ACTUALLY HOLD ON TO THE TUBING FOR THE BAG. ABOUT 2 HOURS LATER, THE PATIENT COULD FEEL PRESSURE IN THEIR PENIS, WHICH EVENTUALLY TURNED OUT TO BE THE BAG, WHICH ONLY RECEIVED 200 ML AND THEN STOPPED RECEIVING URINE. SO THE TUBING FELT UP, AND THEY FELT THE TUBING PRESSURE BACK END INTO THEIR PENIS. SO THEY EMPTY THE BAG AND START OVER AGAIN, HANGING THE BAG ON THE BED RAIL WITH NO KINKS IN THE TUBING, AND AN HOUR AND A HALF LATER, THE SAME THING HAPPENED. POSSIBLE 150-200 ML, AND THEN IT WOULD STOP WORKING. THEY TOOK A BREAK FROM THE DEVICES FOR A COUPLE NIGHTS AND USED OVERNIGHT DISPOSABLE UNDERWEAR, AND THEN THEY GOT A NEW BAG OUT, AND THE SAME THING HAPPENED LAST NIGHT. AS PER FOLLOW-UP VIA PHONE ON 19MAY2023, IT WAS REPORTED THAT THE CUSTOMER'S CUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070997 ↗
• MalfunctionJun 5, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER HAD SAME DRAIN BAG THEY HAVE CALLED ABOUT. STATED THAT THEY USE IT AT NIGHT ONLY, DURING THE NIGHT PATIENT HAD TO GET UP MULTIPLE TIMES TO EMPTY IT BECAUSE THEY FEEL PRESSURE FROM THE TUBING OR BAG LIKE IT WAS NOT DRAINING. REPRESENTATIVE REVIEWED POSSIBLE VAPOR LOCK ON NEW BAG AND EXPLAINED HOW TO SEPARATE MATERIAL TO BREAK VAPOR LOCK WHICH MIGHT CAUSE URINE TO BACK UP INTO TUBING. ALSO EXPLAINED HOW SYSTEM COULD VAPOR LOCK IF THE AIR VENT GETS WET. PATIENT DENIES GETTING VENT WET. PER FOLLOW-UP VIA PHONE ON 19MAY2023, IT WAS REPORTED THAT THE CUSTOMER'S CURRENT SUPPLIER WAS VITALITY MEDICAL AND THE CUSTOMER WAS DEALING WITH INCONTINENCE AND SLEPT ON THEIR LEFT SIDE WITH THE DRAIN BAG ATTACHED TO THEIR BED RAIL ROUGHLY BELOW THEIR HIP. THE PRESSURE THEY HAD BEEN FEELING WAS MAINLY IN THE PENIS, AND THE DRAIN BAG WAS ONLY LEVELLING OUT TO 300 CC. THEY RAN WATER THROUGH THE DRAIN BAG AT TIMES TO SEE IF THE ISSUE WOULD RESOLVE ITSELF, AND SOMETIMES IT DID NOT. THE RESULTS WERE THE SAME REGARDLESS. THEY NOTICED THE PRESSURE BUILDUP EVERY 2 HOURS AFTER REAPPLYING THEIR TEXAS CATHETER TO THE DRAIN BAG, AND THEY JUST HAD AN ARTIFICIAL SPHINCTER ACTIVATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058244 ↗
• MalfunctionMay 22, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DRAIN BAG WAS LEAKING AT THE BOTTOM AROUND GREEN SEAL. ANOTHER ONE TUBING WAS LAID WRONG AND BENT. PATIENT THOUGHT THAT BOTH OF THE BAGS WERE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973708 ↗
• MalfunctionMay 16, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAINAGE BAG HOSE DID NOT WORK WITH URINE. URINE DID NOT GO THROUGH HOSE, IT GOT STUCK BEFORE EMPTYING OUT INTO BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938857 ↗
• MalfunctionMay 8, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAGS WERE FAULTY AND ITS WOULD NOT DRAIN. REPRESENTATIVE OFFERED TO HAVE DRAIN BAGS TO THE PATIENT. PATIENT COULD NOT LOCATE BAGS JUST SHIPPED OUT 4/6 AND ARRIVED 4/7. REPRESENTATIVE TOLD PATIENT TO CALL BACK THE DRAIN BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885830 ↗
• MalfunctionApr 3, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRAIN BAG WAS MORE RIGID THAN WHAT THE PATIENT HAD GOT IN THE PAST. THE PATIENT STATED THAT THE HOSE WOULD TWIST AND CAUSE THE CATHETER TO COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16663360 ↗
• MalfunctionMar 30, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE TUBING WAS NOT WITH THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644418 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION THAT WAS PERMANENT. PATIENT PREVIOUSLY SPOKE WITH ANOTHER REPRESENTATIVE AND ASKED ABOUT A PARTICULAR DRAIN BAG AND THE REPRESENTATIVE COULD NOT PROVIDE IT SINCE IT WAS PRODUCED BY A COMPETITOR. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 16589962 ↗
• MalfunctionMar 15, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING URINARY DRAINAGE BAGS FOR ABOUT 4 MONTHS WITH NO ISSUES UNTIL NOW. THIS PARTICULAR LOT THEY GONE THROUGH MULTIPLE BAGS WITH THE SAME ISSUE. URINE WAS NOT DRAINING DOWN THE TUBING INTO THE BAG. THEY HAD TO PUSH IT DOWN AND HEARD A WHOOSHING SOUND ONCE THE URINE STARTED TO MOVE. REPRESENTATIVE VERIFIED POSITION OF BAG AND TUBING THAT ALLOWED GRAVITY TO ADVANCE URINE. IT WAS NOTED THAT THE PATIENT DENIED WEARING BAG WHILE SHOWERING, DISCUSSED VAPOR LOCK AND EFFECTS OF HUMIDITY. SUGGESTED TO EXERCISE THE SIDES OF THE BAG IN ORDER TO ENSURE THAT URINE CAN FLOW INTO THE BAG AS DESIGNED. PER ADDITIONAL INFORMATION RECEIVED ON 28FEB2023, IT WAS REPORTED THAT THE CUSTOMER WAS NOW EXPERIENCING THE SAME ISSUE WITH A DIFFERENT PRODUCT. THE CUSTOMER WAS RECOMMENDED TO USE DRAINAGE BAG (REF# (B)(4)) AFTER THEIR INITIAL PRODUCT STOPPED WORKING. THE CUSTOMER STATED URINE WAS NOW BACKING UP INTO THE OSTOMY BAG. ALSO STATED THAT THERE WAS AN UNUSUAL NOISE. THIS HAD CAUSED THE CUSTOMER A LOT OF DISCOMFORT AND THEY WERE UNABLE TO SLEEP DURING THE NIGHT DUE TO THE NEED TO FREQUENTLY CLEAR THE BAG MANUALLY BY SQUEEZING THE URINE OUT TO PREVENT SOILING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544763 ↗
• MalfunctionJan 30, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE DRAINAGE BAG ARRIVED WITHOUT THE GREEN CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16267108 ↗
• MalfunctionJan 30, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT USED THE DRAIN BAG WOULD NOT OPEN THEREFORE THE URINE COULD NOT BE DRAINED. PER ADDITIONAL INFORMATION RECEIVED FROM LIBERATOR ON 09JAN2023, ONE OF THE DRAIN BAGS THEY RECEIVED WAS GLUED TO ANOTHER ONE OR TO ITSELF HENCE THEY COULD NOT USE IT. IT WAS MENTIONED AS AN OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264123 ↗
• InjuryDec 5, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION FROM REUSING DRAIN BAGS BECAUSE THE PATIENT COULD NOT REMEMBER TO PLACE ORDER. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 15916566 ↗
• MalfunctionDec 1, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT INITIALLY CUSTOMER HAS BEEN USING 802002 DRAIN BAG AS IT WAS DISCONTINUED CUSTOMER WAS PROVIDED WITH 802001 DRAIN BAG. IT WAS REPORTED THAT THE DRAIN BAG WAS CLOGGED. REPRESENTATIVE EXPLAINED THAT 802001 IS THE EXACT REPLACEMENT OF 802002. ALSO STATED THAT IF THE BAG WAS CLOGGED IT COULD HAVE BEEN DUE TO SEDIMENTS AND BRIEFED THAT THERE IN NO CHANGE IN FUNCTIONALITY OF THE 802001 DRAIN BAG. CUSTOMER ALSO REPORTED THAT THE DRAIN BAG WAS LEAKING EVERYWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899943 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LOT OF INFECTIONS, AND THEY WERE WONDERING IF NOT CLEANING THE BAG WAS CAUSING. IT WAS STATED THAT THE OCCASIONAL PATIENT HAD BLOOD IN BAG AND PATIENT TAKES HUMIRA AND HAD FIVE AUTO DISORDER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15680665 ↗
• MalfunctionOct 27, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE LEG BAGS WERE LEAKING. AS PER FOLLOW UP VIA PHONE ON 15OCT2022, IT WAS REPORTED THAT THE DRAIN BAG LEAKED AT THE INLET TUBE, AND THE CLAMP WAS NOT STAYING CLOSED AND LEAKING. THE CUSTOMER HAD TO BUY PIECES FROM HOME DEPOT TO KEEP IT CLOSED. ALSO STATED THAT URINE WAS BACKING UP FROM THE ANTI-REFLUX VALVE. CUSTOMERS ALSO HAVE A NEW ONE CURRENTLY LEAKING FROM THE TOP AND ALSO HAVING AN ISSUE WITH THE CLAMP STAYING CLOSED. THE CUSTOMER STATED THEY ALSO HAD A BLADDER INFECTION EVERY MONTH FOR A YEAR AND HAD BEEN PRESCRIBED VARIOUS ANTIBIOTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679404 ↗
• MalfunctionSep 9, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG HAD BLOWN THE EXTERNAL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391228 ↗
• MalfunctionAug 1, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WOULD NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138614 ↗
• MalfunctionJul 15, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG DID NOT DRAIN. IT WAS NOTED THAT THE CUSTOMER WAS NOT AN LIBERATOR MEDICAL SERVICE (LMS) CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026376 ↗
• MalfunctionMay 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DRAIN BAG HAD YELLOW STAINS ON THE BAG AND THE CLAMP ON THE BAG WAS LOOSE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429258 ↗