Bard® Urinary Drainage Bag 154004ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741029554), received between Jul 2, 2018 and Sep 4, 2026 — classified as 1 injury, 31 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Deformation Due to Compressive Stress

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 50612427 ↗
• MalfunctionJul 1, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG URINARY BLOCKAGE OCCURRED, AND DRAINAGE DID NOT OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371897 ↗
• MalfunctionJun 11, 2024Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS BAD DRAIN BAG MOLDING. THE PART THAT DISPOSES OF URINE WAS CRIMPED AND OBSTRUCTED URINE FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508917 ↗
• MalfunctionDec 26, 2023Restricted Flow rate; Fluid/Blood Leak; Restricted Flow rate; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE DID NOT FLOW FROM THE DRIP CHAMBER TO THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394764 ↗
• MalfunctionSep 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT URINE LEAKED FROM THE DRAIN BAG. AFTER THE DEVICE WAS PLACED ON THE PATIENT, URINE LEAKED FROM THE DRAIN BAG. THE DURATION OF USE WAS UNKNOWN. THE LEAKAGE LOCATION WAS UNKNOWN. NO DAMAGE COULD BE FOUND THROUGHOUT THE BAG. AS PER MAIL RECEIVED FROM IBC ON 31AUG2023, THE INITIAL REPORTED EVENT WAS WRONG. THE CORRECT EVENT WAS THAT AFTER THE BALLOON WAS PLACED IN THE PATIENT, STERILE WATER LEAKED AND THE BALLOON FELL OUT. DETENTION PERIOD WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744690 ↗
• MalfunctionJul 18, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE ON (B)(6) WITH A FOLEY CATHETER THAT WAS MISSING THE BOTTOM CONNECTER THAT LET THEM DRAIN IT. INSTEAD, IT JUST HAD A HOLE WHERE IT SHOULD BE LEAVING THE BAG OPEN TO AIR. THEY HAD TO OPEN A SECOND KIT TO GET THE CLAMP OUT OF IT. PER FOLLOW UP VIA EMAIL RECEIVED ON 11JUL2023, NO SAMPLE AVAILABLE. THE FOLEY WAS DISCARDED UPON DISCOVERING THE ISSUE AS IT HAD TOUCHED THE PATIENT. THE PATIENT STATUS WAS DISCHARGED. THE SITUATION WAS FIXED IMMEDIATELY FROM PLACEMENT AS THEY REALIZED THE BAG WAS OPEN WHEN HANGING IT. THE PRODUCT WAS NONFUNCTIONAL AS THERE WAS A HOLE IN THE COLLECTION BAG WHERE THE EMPTYING SPOUT SHOULD HAVE BEEN. CUSTOMER THEN HAD TO OPEN ANOTHER KIT TO REPLACE THE BAG SO THERE WAS NOT ANY SPILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342628 ↗
• MalfunctionNov 21, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS SHORTAGE OF PARTS. IT WAS STATED THAT IMMEDIATELY AFTER USE, THE OUTLET TUBE WAS FOUND NOT TO BE ATTACHED TO THE DRAIN BAG. IT WAS MENTIONED THAT HEALTH DAMAGE TO THE PATIENT WAS UNKNOWN. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 14NOV2022, IT WAS STATED THAT THE OUTLET TUBE WAS NOT ATTACHED TO THE DRAIN BAG. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833488 ↗
• MalfunctionAug 22, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSE USED THE FOLEY KIT TO REPLACE A CATHETER AND FOUND THAT THE DRAINAGE BAG WAS MISSING THE SPOUT TO DRAIN THE URINE OUT AS WELL AS PREVENT IT FROM LEAKING CONTINUOUSLY FROM THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15270362 ↗
• MalfunctionJun 10, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED NEW SHIPMENT OF URINE DRAINAGE BAGS (PCN - 154114A) AND WOULD LIKE TO COMPARE HOW THE DRAIN BAG (PCN - 154114A) WAS DIFFERENT FROM THE DRAIN BAG (PCN - 154004A). CURRENT BAG ON THE PATIENT APPEARED TO HAVE THE SAME DRAINAGE SPOUT. INQUIRER IDENTIFIED THAT THE CURRENT DRAIN BAG ON PATIENT WOULD HAVE A CERAMIC INSERT IN IT. FROM WHAT INQUIRER COULD SEE IT DID NOT BECAUSE PATIENT WAS ABLE TO PINCH TUBING COMPLETELY AND DID NOT FEEL AN INSERT. PATIENT HAD THREE BAGS LEFT OF 154004A. DRAINAGE BAG CURRENTLY IN USE WAS ONE OF THOSE THREE YET IT DID NOT HAVE THAT INSERT IN IT. CUSTOMER OPENED ANOTHER 154004A PACKAGE AND COULD FEEL THE INSERT INSIDE THE DRAINAGE SPOUT AND NOTED THAT THE BAG IN USE RIGHT NOW, THAT WAS SUPPOSED TO BE A 154004A BAG, FEELS EXACTLY LIKE THE NEW BAGS (154114A). CUSTOMER WAS SURE IT WAS SUPPOSED TO BE 154004A WITH AN INSERT AS IT WAS THE ONLY BAG THEY USED UP UNTIL IT WAS DISCONTINUED AND REPLACED WITH THE BAGS THEY RECEIVED TODAY (154114A).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653688 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN USING DRAIN BAG 154004A FOR MANY YEARS AND HAD RECENTLY GIVEN DRAIN BAG 154114A. THE CUSTOMER WAS NOT SURE WHY AND WOULD LIKE TO KNOW THE DIFFERENCE BETWEEN DRAIN BAGS BECAUSE THE PATIENT SUFFERED FROM URINARY TRACT INFECTIONS OFTEN. 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 14601685 ↗
• MalfunctionMay 7, 2022Inaccurate Flow Rate; Component Misassembled; Inaccurate Flow Rate; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW FROM THE FOLEY CATHETER TO THE DRAIN BAG ON THE DAY OF USE. PER FOLLOW UP VIA IBC ON 21APR2022, THE CATHETER HAD NO BLOCKAGE BUT THERE WAS A FILM IN THE CHAMBER OF THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316356 ↗
• MalfunctionFeb 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE URINE LEAKED FROM THE CONNECTING PART BETWEEN THE DRAIN BAG AND THE URINATION PORT ON THE 4TH DAY OF PLACEMENT. PER SAMPLE EVALUATION FROM INVESTIGATOR VIA EMAIL ON 18JAN2022, IT WAS CONFIRMED THAT BASED ON THE SECOND SAMPLE EVALUATION THERE WAS PVC MATERIAL BETWEEN THE INLET TUBING AND THE DOME. PER ADDITIONAL INFORMATION RECEIVED ON 26JAN2022, THERE WERE NO LEAKS FOUND DURING SAMPLE EVALUATION. HOWEVER, DURING FURTHER EVALUATION, IT WAS NOTED THAT THERE WAS PVC MATERIAL BETWEEN THE INLET TUBING AND THE DOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480950 ↗
• MalfunctionDec 10, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DRAIN BAG HAD A PIECE OF WHITE MATERIAL IN IT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 30NOV2021, IT WAS REPORTED TO HAVE BEEN USED ON PATIENTS AND WHITE SHEET WAS CRIMPED TOGETHER WITH THE BASE OF THE OUTLET TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977714 ↗
• MalfunctionNov 18, 2021Device Contamination with Chemical or Other Material; Component Misassembled; Device Contamination with Chemical or Other Material; Component Misassembled

  IT WAS REPORTED THAT AFTER USE, URINE FLOW WAS STOPPED AND DID NOT DRIP INTO THE DRAINAGE BAG. THE URINE WAS ACCUMULATED IN THE PATIENT BLADDER. IT WAS NOTED THAT THERE WAS A FILM ON THE CYLINDER OF THE DRIP CHAMBER. PER FOLLOW UP INFORMATION RECEIVED ON 18NOV2021, THERE WAS A FILM (LIKE TRANSLUCENT MEMBRANE) INSIDE OF THE CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834824 ↗
• MalfunctionNov 16, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT AFTER USE, URINE FLOW WAS STOPPED AND DID NOT DRIP INTO THE DRAINAGE BAG. THE URINE WAS ACCUMULATED IN THE PATIENT BLADDER. IT WAS NOTED THAT THERE WAS A FILM ON THE CYLINDER OF THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821146 ↗
• MalfunctionOct 1, 2021Restricted Flow rate; Component Misassembled; Restricted Flow rate; Component Misassembled

  IT WAS REPORTED THAT NO URINE FLOWED INTO THE DRAIN BAG FOR FIVE HOURS AFTER THE PLACEMENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 15SEP2021, IT WAS CONFIRMED THAT POOR URINE FLOW OCCURS AT THE CONNECTION AREA BETWEEN THE BAG AND THE INLET TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563404 ↗
• MalfunctionSep 28, 2021Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS NO URINE FLOW, AND THE CUSTOMER FOUND A FOREIGN OBJECT ATTACHED TO THE DRAIN BAG FILTER AREA ON THE DAY OF PLACEMENT. THE CUSTOMER PEELED IT OFF AND URINE FLOWED. NO ABNORMALITIES HAD BEEN OBSERVED UPON VISUAL INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541542 ↗
• MalfunctionSep 28, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT NO URINE FLOWED INTO THE DRAIN BAG AFTER THE PLACEMENT. AFTER INSPECTION, A TRANSLUCENT MEMBRANE WAS OBSERVED BETWEEN THE TUBE AND THE BAG. THE PATIENT STATED THAT THE BLADDER BECAME SICK AND IT TOOK TIME TO TREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541408 ↗
• MalfunctionSep 21, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE FLOW RATE FROM THE FOLEY CATHETER TO THE DRAIN BAG WAS RESTRICTED AFTER ONE HOUR OF PLACEMENT. IT WAS ALSO REPORTED THAT URINE DID NOT FLOW AFTER REPLACEMENT. THERE WAS NO KINK OR BEND IN THE CATHETER. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 02SEP2021, IT WAS CONFIRMED THAT POOR URINE OCCURRED IN THE DRAIN BAG AND ¿DONYO CHUBU¿ IN JAPANESE MEANS INLET TUBE, DOES NOT MEAN CATHETER. IT WAS CONFIRMED THAT POOR URINE FLOW OCCURRED IN THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506162 ↗
• MalfunctionSep 15, 2021Restricted Flow rate; Component Misassembled; Restricted Flow rate; Component Misassembled

  IT WAS REPORTED THAT THE URINE DID NOT FLOW INTO THE DRAINAGE BAG AND HAD STOPPED NEAR THE DRIP CHAMBER. THE FLOW OF URINE ALLEGEDLY STOPPED NEAR THE DOME OF THE BAG. PER SAMPLE EVALUATION FROM INVESTIGATOR VIA EMAIL ON 18FEB2022, THE INLET TUBING OF THE DRAIN BAG WAS NOTED TO BE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474601 ↗
• MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE LEAKED FROM THE SHAFT BETWEEN THE TAMPER EVIDENT SEAL AND THE TIP ON THE 6TH DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455568 ↗
• MalfunctionSep 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER FOUND A PIECE OF PAPER FLOATING IN THE DRAIN BAG ON THE 2ND DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439712 ↗
• MalfunctionAug 22, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT URINE DID NOT FLOW FROM THE INLET TUBE TO THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352163 ↗
• MalfunctionAug 22, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DID NOT FLOW INTO THE BAG ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352129 ↗
• MalfunctionAug 18, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE DID NOT FLOW INTO THE DRAIN BAG ON THE DAY OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337197 ↗