Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154006Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741029615), received between Feb 2, 2018 and Nov 18, 2025 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (13 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 27 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 14, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DRAIN BAG COULD NOT COLLECT URINE DUE TO THE SAMPLING PORT HAD A CHECK VALVE THAT WAS BLOCKING THE URINE. CUSTOMER STATED THE OTHER DRAIN BAGS THEY HAD DID NOT HAVE THE BLUE PIECE. WENT OVER TROUBLESHOOTING BAG WITH WATER, BUT PATIENT SENT PHOTO OF A BLUE PIECE THAT WAS USED FOR SAMPLING AND INFORMED IT WAS BLOCKING IT PREVENTING ANY URINE FROM DRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384467 ↗
• MalfunctionAug 2, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER USED THE DRAIN BAG (PCN#154006) FOR 10 YEARS AND REALLY ENJOYED THE TEAR DROP SHAPE OF THE URINARY DRAINAGE BAG. STATED THAT THEY RECEIVED THE SAME 154006 FROM THEIR SUPPLIER AND NOTICED A NEW SHAPE TO THE BAG WHICH SUCKED. ALSO STATED THAT THE URINE DID NOT GO TO THE DRAINAGE OUTLET IN THE SQUARE SHAPE AS WELL AS IT DID FOR THE TEAR DROP SHAPE (FORMER DESIGN OF 154006). PER FOLLOW UP VIA PHONE ON 08OCT2024, IT WAS REPORTED THAT CUSTOMER DID NOT LIKE THE NEW DESIGN OF THE DRAIN BAGS. THEY SAID THAT BAGS WERE TEAR SHAPED AND NOW THE SQUARE SHAPE DID NOT WORK FOR THEM BECAUSE IT WAS HARD TO CLEAN AND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19892131 ↗
• MalfunctionMar 29, 2024

  BARD URINARY DRAINAGE BAG EZ-LOK 2000ML OVERNIGHT BAG REF # 154006. PATIENTS ARE COMPLAINING THAT THEY LEAK AT THE BOTTOM WITH THE GREEN CLAMP. THE CLAMP WAS NOT CLOSING OR NOT CLICKING TO LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003408 ↗
• MalfunctionJan 31, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG STOPPED DRAINING PROPERLY AND CAUSED THE URINE TO BACK UP AND LEAK EVERYWHERE. THEY RAN WATER THROUGH IT AND THE BAG DID NOT DRAIN PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613151 ↗
• MalfunctionJan 29, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAINAGE BAG WAS NOT DRAINING PROPERLY. THEY STATED THAT IT CAUSED THE EXTERNAL CATHETER TO EXPAND LIKE A BALLOON AND LEAK URINE EVERYWHERE. PATIENT STATED IT WAS WORKING FOR A FEW DAYS AND THEN STOPPED AND THEY RAN WATER THROUGH IT. PER SAMPLE RECEIVED ON (B)(6) 2024, IT WAS NOTED THAT THE CUSTOMER RETURNED MALE EXTERNAL CATHETERS 3 WITH MATERIAL# 38303, BATCH# (B)(4) AND 1 WITH MATERIAL#38303 AND BATCH# (B)(4) WERE RETURNED FOR EVALUATION. PER FOLLOW UP ON (B)(6) 2024, IT WAS REPORTED THAT SAMPLES WERE RETURNED OF DEFECTIVE MALE EXTERNAL CATHETERS THAT WERE NOT LONG ENOUGH. CUSTOMER STATES HE WAS UNABLE TO GET THE CATHETERS ON BECAUSE THEY WERE TOO SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596091 ↗
• MalfunctionJan 8, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS HARDER TO DRAIN, CUSTOMER WAKING UP NUMEROUS TIMES AT NIGHT TO CHECK IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464407 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  IT WAS REPORTED THAT THE DRAIN BAGS WERE NOT EASY TO CLEAN SO THEY GAVE PATIENT HAD A URINARY TRACT INFECTION AND THE PATIENT HAD BLEEDING. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS AND BLEEDING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Tract Infection

  MAUDE report 18215518 ↗
• MalfunctionNov 21, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT IT WAS DIFFICULT TO DRAIN THE BAG AND WAS UNABLE TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181795 ↗
• MalfunctionNov 14, 2023Collapse; Collapse

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE 154006-DRAINAGE BAG AS WELL AS THE HOLLISTER BELLY BAG FOR THEIR STOMA. THEY HAD BEEN CONNECTING THE BARD BAG TO THE BOTTOM OF THE HOLLISTER BAG. THEY BROUGHT A NEW NIGHTTIME DRAINAGE BAG (154006). WHEN THEY CAME BACK AND GOT READY TO CHANGE THE HOLLISTER BAG OUT, THERE WAS A PURPLE RING AROUND THEIR STOMA ON THEIR SKIN. (LOT# NGHS2501) (LOT# NGHS0129) THEY SAID IT WAS ITCHY BUT WAS NOT PAINFUL AND IT DID NOT HURT. IT WAS NOT THERE PRIOR TO THEM LEAVING. THEY HAVE BEEN TO THE DOCTOR'S OFFICE, THE DOCTOR DID NOT SEE THEM, BUT THEY SAW A NURSE PRACTITIONER AND AN LPN. THEY DID PUT THEM ON 3 DAYS¿ WORTH OF ANTIBIOTICS. THEY ADVISED THEM TO GO TO THIS POUCH STORE THAT SOLD THESE SORTS OF PRODUCTS FOR STOMAS. THERE, THEY HAD AN APPOINTMENT SET UP WITH A UROSTOMY NURSE NEXT WEEK. THEY HAD BEEN ON THE PHONE FOR 2HOURS AND 15MINUTES TRYING TO GET SOME HELP. THEY HAD ALREADY SPOKE WITH HOLLISTER WHO SAID THEY WERE NOT FAMILIAR WITH ANYONE WITH THIS PROBLEM. THEY HAD ITEM 154006 CONNECTED TO THEIR UROSTOMY BAG. THEY HAD NOTICED THAT THE DRAINAGE BAG SEEMED TO BE CAUSING THE UROSTOMY BAG TO COLLAPSE (LOT# NGHS2501) (LOT# NGHS0129). WHEN THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133678 ↗
• InjuryNov 14, 2023Nonstandard Device; Patient Device Interaction Problem; Nonstandard Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE 154006-DRAINAGE BAG AS WELL AS THE HOLLISTER BELLY BAG FOR THEIR STOMA. THEY HAD BEEN CONNECTING THE BARD BAG TO THE BOTTOM OF THE HOLLISTER BAG. THEY BROUGHT A NEW NIGHT TIME DRAINAGE BAG (154006). WHEN THEY CAME BACK AND GOT READY TO CHANGE THE HOLLISTER BAG OUT, THERE WAS A PURPLE RING AROUND THEIR STOMA ON THEIR SKIN. (LOT# NGHS2501) (LOT# NGHS0129) THEY SAID IT WAS ITCHY BUT WAS NOT PAINFUL AND IT DID NOT HURT. IT WAS NOT THERE PRIOR TO THEM LEAVING. THEY HAVE BEEN TO THE DOCTOR'S OFFICE, THE DOCTOR DID NOT SEE THEM, BUT THEY SAW A NURSE PRACTITIONER AND AN LPN. THEY DID PUT THEM ON 3 DAYS WORTH OF ANTIBIOTICS. THEY ADVISED THEM TO GO TO THIS POUCH STORE THAT SOLD THESE SORTS OF PRODUCTS FOR STOMAS. THERE, THEY HAD AN APPOINTMENT SET UP WITH A UROSTOMY NURSE NEXT WEEK. THEY HAD BEEN ON THE PHONE FOR 2HOURS AND 15MINUTES TRYING TO GET SOME HELP. THEY HAD ALREADY SPOKE WITH HOLLISTER WHO SAID THEY WERE NOT FAMILIAR WITH ANYONE WITH THIS PROBLEM. THEY HAD ITEM 154006 CONNECTED TO THEIR UROSTOMY BAG. THEY HAD NOTICED THAT THE DRAINAGE BAG SEEMED TO BE CAUSING THE UROSTOMY BAG TO COLLAPSE (LOT# NGHS2501) (LOT# NGHS0129) . WHEN THE

  Patient problems: Itching Sensation; Rash

  MAUDE report 18133672 ↗
• InjuryNov 14, 2023Nonstandard Device; Patient Device Interaction Problem; Nonstandard Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING THE 154006-DRAINAGE BAG AS WELL AS THE HOLLISTER BELLY BAG FOR THEIR STOMA. THEY HAD BEEN CONNECTING THE BARD BAG TO THE BOTTOM OF THE HOLLISTER BAG. THEY BROUGHT A NEW NIGHTTIME DRAINAGE BAG (154006). WHEN THEY CAME BACK AND GOT READY TO CHANGE THE HOLLISTER BAG OUT, THERE WAS A PURPLE RING AROUND THEIR STOMA ON THEIR SKIN. (LOT# NGHS2501) (LOT# NGHS0129) THEY SAID IT WAS ITCHY BUT WAS NOT PAINFUL AND IT DID NOT HURT. IT WAS NOT THERE PRIOR TO THEM LEAVING. THEY HAVE BEEN TO THE DOCTOR'S OFFICE, THE DOCTOR DID NOT SEE THEM, BUT THEY SAW A NURSE PRACTITIONER AND AN LPN. THEY DID PUT THEM ON 3 DAYS¿ WORTH OF ANTIBIOTICS. THEY ADVISED THEM TO GO TO THIS POUCH STORE THAT SOLD THESE SORTS OF PRODUCTS FOR STOMAS. THERE, THEY HAD AN APPOINTMENT SET UP WITH A UROSTOMY NURSE NEXT WEEK. THEY HAD BEEN ON THE PHONE FOR 2HOURS AND 15MINUTES TRYING TO GET SOME HELP. THEY HAD ALREADY SPOKE WITH HOLLISTER WHO SAID THEY WERE NOT FAMILIAR WITH ANYONE WITH THIS PROBLEM. THEY HAD ITEM 154006 CONNECTED TO THEIR UROSTOMY BAG. THEY HAD NOTICED THAT THE DRAINAGE BAG SEEMED TO BE CAUSING THE UROSTOMY BAG TO COLLAPSE (LOT# NGHS2501) (LOT# NGHS0129). WHEN THEY

  Patient problems: Itching Sensation; Rash

  MAUDE report 18133564 ↗
• MalfunctionOct 10, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PATIENT USED OVERNIGHT BAG 154006 WITH THEIR OSTOMY BAG. PATIENT STATED URINE DID NOT FLOW FROM THIS OSTOMY POUCH INTO THEIR DRAINAGE BAG AS IT SHOULD, AND PATIENT HAS TO MANUALLY PUSH THE URINE DOWN AT TIMES. PATIENT ADVISED THERE WAS NO CONNECTION PROBLEM BETWEEN THE ADAPTER AND OVERNIGHT BAG (SNUGLY CONNECTED). REPRESENTATIVE EXPLAINED TO CUSTOMER THAT BD DID NOT MANUFACTURE THE OSTOMY POUCH/ADAPTER, HOWEVER THEY SHOULD BE UNIVERSAL. PATIENT MENTIONED THEY CLEAN IT AND REUSE IT AND HAVE BEEN USING THIS SAME BAG SINCE AUGUST. THE OVERNIGHT NIGHT BAG DID UTILIZE A VENTED PORT TO ALLOW FOR AIR EXCHANGE AND WOULD CAUSE THE SYSTEM TO VAPOR LOCK SHOULD IT BECOME SATURATED. BD CANNOT RECOMMEND THE CLEANING AND REUSE OF THIS BAG AS IT WAS LABELED SINGLE USE. SUGGESTED SPEAKING TO THE MANUFACTURER OF THE POUCH/ADAPTER TO SEE IF THEY HAVE ANY ADDITIONAL RECOMMENDATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904339 ↗
• MalfunctionSep 28, 2023Restricted Flow rate; Insufficient Device Problem Information; Restricted Flow rate; Insufficient Device Problem Information

  IT WAS REPORTED THAT CUSTOMER NOTICED A DESIGN FLAW IN A URINARY DRAIN BAG. PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, PATIENT WAS MERELY REPORTING FINDINGS BASED ON PERSONAL EXPERIENCE WITH A BD URINE COLLECTION BAG. IT WAS STATED THAT AFTER THE TRANS URETHRAL RESECTION OF BLADDER TUMOR SURGERY, A FOLEY CATHETER WAS INSERTED AND ATTACHED TO A BARD DRAINAGE BAG. UNDER SOME CONDITIONS THE BAG MAY CREATE A SUCTION EFFECT WHEN DRAINED. WHICH COULD LEAD TO A BLADDER INFECTION. AFTER EMPTYING THE BAG A THIRD TIME, THEY NOTICED THE BAG WAS NO LONGER LIMP. INSTEAD OF BEING FILLED WITH AIR ABOVE A POOL OF URINE, THE CLEAR FRONT AND REAR BAG SURFACES HAD COLLAPSED TOGETHER, SUCKING DOWN THE AIR VENT. THE AIR LEAK WAS EFFECTIVELY SEALED SHUT AND NO LONGER ASSURED THE INSIDE OF THE BAG REMAINED AT ATMOSPHERIC PRESSURE. IN ADDITION, WITHOUT A FUNCTIONAL AIR RELIEF VALVE, SURFACE TENSION PREVENTED AIR FROM LEAKING BACK INTO THE BAG THROUGH THE DRAIN WHEN IT WAS OPENED. AS THE URINE WAS DRAINED FROM THE BAG, A NEGATIVE PRESSURE INSIDE THE BAG DEVELOPED. IT LOOKED LIKE A FOOD-SAVER VACUUM BAG. THIS NEGATIVE PRESSURE SUCKED ON THE BLADDER, AND COULD ONLY BE RELIEVED BY AIR LEAKING BETWEEN THE CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835378 ↗
• InjurySep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DRAIN BAGS WERE LEAKING FROM THE BOTTOM DRAIN. IT WAS STATED THAT THIS HAD NOW HAPPENED TO MULTIPLE BAGS FROM THIS BATCH. IT WAS ALSO STATED THAT AT LEAST FIVE BAGS HAD BEEN REPORTED TO BE LEAKING. IT WAS NOTED THAT THE USER WAS EXPOSED TO BLOOD, OR BODILY FLUIDS AND THE DETAILED EXPOSURE WAS URINE. THE DETAILED SAFETY ISSUE WAS MENTIONED AS EXPOSED TO URINE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 17817825 ↗
• MalfunctionMay 21, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PLASTIC CYLINDER AT THE BOTTOM OF THE DRAIN BAG RELEASED WITH LITTLE TO NO PRESSURE. IT WAS ALSO STATED THAT NORMALLY THE LEVER HOLDS IT IN BUT THIS DRAIN BAG DID NOT HAVE A DE-TENT. AS PER THE FOLLOW UP VIA PHONE ON 05MAY2022, IT WAS REPORTED THAT THE CUSTOMER DID NOT HAVE THE DEFECTIVE DRAIN BAG LOT NUMBER, BUT THEY HAVE THE SAMPLE TO RETURN. IT WAS STATED THAT NO MEDICAL INTERVENTIONS OR CONCERNS OCCURRED CONCERNING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 25MAY2022, STATED THAT IT DID NOT STAY IN CLOSED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466650 ↗
• MalfunctionFeb 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE DRAIN VALVE MISLOCATED AND IT WAS SITTING IN A LOCATION AND MADE IT HARD TO DRAIN THE URINE. PER SAMPLE RECEIVED ON (B)(6) 2022, CUSTOMER RETURNED DRAIN BAGS WITH TWO DIFFERENT LOTS NGFW1355 AND NGFQ1708.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480503 ↗
• MalfunctionOct 22, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE DISTAL END OF THE TUBING THAT CONNECTS TO THE URINARY CATHETER WAS FOUND TO HAVE AN EXTRA BLUE FILTER THAT CAUSED AN OBSTRUCTION OF URINE FROM THE PATIENT TO THE BAG. THIS CAUSED URINARY RETENTION TO THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06OCT2021, EXTRA BLUE FILTER WAS THERE ONLY ON THIS PRODUCT. NO MEDICATIONS WERE GIVEN FOR URINARY RETENTION.

  Patient problems: Urinary Retention

  MAUDE report 12682316 ↗
• MalfunctionOct 6, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INCORRECT PRODUCT MARKED IN A 154006 PACKAGE WHICH CAME THROUGH CARDINAL HEALTH AND WAS SENT BY INDE-MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584720 ↗
• MalfunctionSep 9, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS LEAKING AND URINE WAS NOT GETTING DRAINED PROPERLY FROM THE TUBING TO THE BAG. THE CUSTOMER STATED THAT IT WAS ALMOST LIKE BLOCKED, BUT THERE WAS NO BLOCKAGE. WHEN THE TUBING WAS TILTED UP THE URINE WENT RIGHT INTO THE BAG, BUT IT WOULD NOT DRAIN WHEN THE TUBING WAS DOWN. THE CUSTOMER TRIED SOME TROUBLESHOOTING WITH THE UROLOGIST, BUT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12448066 ↗
• MalfunctionMar 22, 2021Disconnection; Restricted Flow rate; Disconnection; Restricted Flow rate

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE FILTER THAT GOES INTO THE BAG AND LOCK DRAINAGE PORT CAME OFF. PER ADDITIONAL INFORMATION VIA EMAIL ON (B)(6) 2021, IT WAS STATED THAT THE URINE WOULD STOP AT THE TUBE AND THE EASY LOCK PORT FELL OFF OF THE SECOND BAG. PER FOLLOW UP ON 26FEB2021, URINE WOULD ENTER THE TOP OF THE BAG, BUT THE FILTER WOULD NOT ALLOW THE URINE TO FLOW INTO THE BAG. THE CUSTOMER REPORTEDLY EMPTIED THE LINE AND TRIED TO BLOW INTO THE BAG BUT IT WOULD NOT EXPAND OR DRAIN. ALSO, EZ LOCK FOR DRAINING THE BAG FELL OFF IN THE MIDDLE OF EMPTYING THE BAG CAUSING URINE TO LEAK OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542045 ↗
• MalfunctionAug 9, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT FLOWING INTO THE DRAIN BAG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881108 ↗
• MalfunctionJul 29, 2019Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE URINE WAS NOT FLOWING INTO THE DRAIN BAG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8837328 ↗
• MalfunctionMay 3, 2019Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN INTO THE TUBE OF THE DRAIN BAG. THE COMPLAINANT REPORTEDLY MANIPULATED THE TUBE AND URINE STARTED TO DRAIN AFTER SEVERAL MINUTES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8577551 ↗
• MalfunctionMay 2, 2019Labelling, Instructions for Use or Training Problem; Component Missing; Component Missing

  IT WAS REPORTED THAT THE COMPLAINANT DID NOT RECEIVE THE INSTRUCTIONS FOR USE WITH THE DRAIN BAG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8575496 ↗