Bard® Urine Meter with Bag 153214ARecalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00801741033162), received between Mar 17, 2020 and Sep 10, 2026 — classified as 6 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (39 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 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: Exposure to Body Fluids

  MAUDE report 50722293 ↗
• MalfunctionAug 3, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124260 ↗
• MalfunctionJul 27, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047592 ↗
• MalfunctionJan 30, 2026Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE EXPERIENCES WHERE THE TUBING TO THE DRAINAGE CONTAINER IS BENT AND STIFF ("KINKED"), WHICH OBSTRUCTS THE DRAINAGE FROM THE TUBING, FOR THE BARD FOLEY TRAYS. UPON CORRECTION, THE TUBING APPEARS TO REVERT TO THE BENT STATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228786 ↗
• MalfunctionJan 23, 2026Disconnection

  IT WAS REPORTED THAT THE REGISTERED NURSE ATTEMPTED TO ASPIRATE URINE FROM THE SAMPLING PORT OF THE FOLEY CATHETER. UPON CONNECTING THE 10ML SYRINGE TO THE SAMPLING PORT, THE PORT'S COLLAR SEPARATED FROM THE DRAINAGE TUBE AND THE VALVE FELL OUT OF THE DEVICE, LEAVING AN OPEN HOLE IN THE DRAINAGE TUBE. THE FOLEY CATHETER WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW CATHETER. DEFECTIVE DEVICE AND LOOSE PARTS PRESERVED FOR INSPECTION, EQUIPMENT IN MANAGERS OFFICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172903 ↗
• MalfunctionDec 19, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE MAIN UNIT OF THE DRAIN BAG MUST BE CLOSED, BUT SINCE IT WAS OPEN, CAUSED URINE TO LEAK OUT AND WANTED IT TO BE FIXED. THE METER SECTION'S GREEN URINE VALVE WAS OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854615 ↗
• MalfunctionDec 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DRAIN BAG TUBING WAS KINKED UPON OPENING OF PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827189 ↗
• MalfunctionNov 11, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING WAS KINKED AND NOT ALLOWING FOR URINE FLOW. CUSTOMER WERE HAVING SOME ISSUES WITH THE CATHETER TUBING FOLDING OVER ON ITSELF AND NOT ALLOWING THE CATHETERS TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526174 ↗
• MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRAIN BAG TUBING WAS BENT AND KINKS WITHOUT KNOWLEDGE. PICTURES ARE ATTACHED. THE TUBING SEEMED TO BE VERY THIN AND CHEAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497579 ↗
• MalfunctionSep 16, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BAG WAS TIGHTLY ATTACHED, AND THE URINE WAS BARELY FLOWING AND WAS HAVING HANDLING DEFECT. SOME PATIENTS HAVE REPORTED THAT THE NEED TO CHANGE THE CATHETER AGAIN IMMEDIATELY AFTER ITS PLACEMENT INCREASED THE PHYSICAL BURDEN ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062573 ↗
• MalfunctionAug 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE USER TRIED TO USE THE DRAIN BAG, BUT THE URINE COLLECTION BAG DID NOT HAVE AN AIR FILTER, AND THE BALLOON DID NOT INFLATE PROPERLY AND COULD NOT BE PLACED IN PLACE, SO THE USER DISCONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916731 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER PLACED, AND THEY NOTICED THAT THE BAG HAD A HOLE IN IT, WHICH FORCED US TO HAVE TO BREAK THE SEAL TO REPLACE THE BAG. IT WAS NOTED THAT THE GIVEN LOT# NGKP2899.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699874 ↗
• MalfunctionJul 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT TUBING KINKS OVER AT THE TOP OF THE METER ON MOST ALL URINE METERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412791 ↗
• MalfunctionMay 20, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT CUSTOMER STATED THAT THE TUBING ON THE METER BAGS WAS CAME OUT OF THE PACKAGING KINKED WHICH WAS PREVENTED THE URINE FROM DRAINING. CUSTOMER RECENTLY EXPLAINED THAT THE DRAIN TUBING KICKSTAND GUIDE PIECE AT THE TOP OF THE BAGS WAS ONLY MEANT FOR THE TUBING TO GO THROUGH ON NON URINE METER DRAIN BAG FOLEY TRAYS. AS THEY CAN SEE IN THE FIRST TWO PHOTOS ABOVE, THE BAG ON THE RIGHT DID NOT HAVE A URINE METER AND THE TUBING WAS NOT POSITIONED WITHIN THE HOLDER. THEY WOULD BE AUDITING THAT COMPONENT AND WOULD LET THEM KNOW IF THEY FIND ADDITIONAL BAGS WITHOUT URINE METERS THAT DID NOT HAD TUBING IN THE HOLDER AS THEY MENTIONED. ADDITIONALLY, THEY WERE TUBING THAT WAS KINKED BECAUSE OF THE POSITIONING DURING PACKAGING. THE PLASTIC THAT WAS USED HAD MEMORY, AND THE SECOND SET OF PHOTOS SHOWS TUBING THAT WAS KINKED AND WAS NOT DRAINED WELL. WHEN THEY PRESSED THE TUBING OPEN, THE URINE BEGAN TO DRAIN. THE CARE TEAM WAS NOTIFIED AND AN RL WILL BE PLACED FOR THAT CATHETER. IP WILL RECOMMEND A NEW DRAINAGE BAG BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052816 ↗
• MalfunctionMay 16, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING WAS NOT PASSED THROUGH THE HOLDER. THIS WAS RESULTING IN KINKED IN THE TUBING. THIS HAS OCCURRED A FEW TIMES. NO ADVERSE EVENT OR PATIENT INJURY. CUSTOMER PROVIDED 2 SEPARATE PRODUCT NUMBERS (PCN#1758SI16 AND PCN#129416M).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036250 ↗
• MalfunctionMay 16, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING WAS NOT PASSED THROUGH THE HOLDER. THIS WAS RESULTING IN KINKED IN THE TUBING. THIS HAS OCCURRED A FEW TIMES. NO ADVERSE EVENT OR PATIENT INJURY. CUSTOMER PROVIDED 2 SEPARATE PRODUCT NUMBERS (PCN#1758SI16 AND PCN#129416M).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036249 ↗
• MalfunctionMar 24, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN OUT OF THE FOLEY CATHETER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676999 ↗
• InjuryMar 13, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 10-15 TIMES IN THE LAST THREE WEEKS WHERE THE DRAIN BAG CONNECTED TO THE METER LEAKED. THE CUSTOMER REPORTED ISSUES WITH LOT# NGJV4633, LOT# NGJW3241. THE CLINICIANS HAD COME IN CONTACT WITH PATIENT URINE. PER FOLLOW UP VIA PHONE ON (B)(6) 2025, IT WAS REPORTED THAT THE BAGS HAD RIPS IN THEM AND WHEN THEY TRIED TO EMPTY THE BAG, THE URINE WOULD SPILL ON THE NURSES AND PATIENTS. THEIR REPRESENTATIVE CAME OUT AND REPLACED THE DEFECTIVE FOLEYS. LOT NUMBERS WERE GIVEN TO THE BD THE REPRESENTATIVE AND CUSTOMER DID NOT HAVE THEM AT HAND TO GIVE THEM TO REPRESENTATIVE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21594239 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT URINE WAS LEAKING BETWEEN THE TEMPERATURE SENSING FOLEY CATHETER AND THE TAMPER EVIDENT SEAL. URINE WAS LEAKING ON FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312169 ↗
• MalfunctionJan 9, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT PLACED IN THE EMERGENCY ROOM, THE FLOW OF URINE FROM THE CONNECTING TUBE TO THE URINE COLLECTION BAG WAS POOR, AND URINE DOES NOT DRIP OUT. SO, THE PROBLEM WAS IMPROVED WHEN THE BAG WAS REPLACED WITH A URINE COLLECTION BAG FROM ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114180 ↗
• MalfunctionDec 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT NURSE SHOWED CUSTOMER ON A CURRENT PATIENT WHERE A KINK WAS OCCURRING AT THE POINT WHERE THE DRAINAGE TUBING WAS CONNECTING TO THE URINE METER. THE STAFF HAD TO CONTINUOUSLY CHECK TO MAKE SURE IT DID NOT KINK OFF. ANOTHER NURSE NOTED THAT THEY HAVE BEEN SEEING KINKING OF THE FOLEY DRAINAGE TUBING IN DIFFERENT AREAS ALONG THE ENTIRE DRAINAGE TUBING, NOT JUST AT THE CONNECTION POINT TO THE URINE METER. THEY ALSO ATTESTED THAT THEY HAD TO KEEP A CLOSE EYE ON THE TUBING THROUGHOUT THE SHIFT. THEY NOTED THAT THIS HAD BEEN HAPPENING FOR A WHILE. CUSTOMER ALSO CHECKED WITH OPERATING ROOM AND ANESTHESIA HAD NOTICED THE KINKING ALSO. TO THEIR RECOLLECTION, IT HAD BEEN HAPPENING FOR 9-12 MONTHS. NURSE ALSO HAD BEEN SEEING KINKING AT VARIOUS POINTS OF THE DRAINAGE TUBING. THEY NOTICED THAT AS THE URINE STARTED COLLECTING IN THE TUBING, IT GOT HEAVY AND PULLS DOWN, KINKING OFF THE DRAINAGE AND CAUSED BACK UP. ON ONE SURGICAL PATIENT, NURSE THOUGHT THE PATIENT HAD A VERY LOW URINE OUTPUT, JUST TO FIND OUT AT THE END OF THE CASE THAT THE TUBING WAS KINKED UP HIGH CLOSER TO THE FOLEY CATHETER CONNECTION, THIS WAS UNDER THE STERILE DRAPE, AND THEY COULD NOT ACCESS IT UNTIL AFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036563 ↗
• MalfunctionDec 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT NURSE SHOWED CUSTOMER ON A CURRENT PATIENT WHERE A KINK WAS OCCURRING AT THE POINT WHERE THE DRAINAGE TUBING WAS CONNECTING TO THE URINE METER. THE STAFF HAD TO CONTINUOUSLY CHECK TO MAKE SURE IT DID NOT KINK OFF. ANOTHER NURSE NOTED THAT THEY HAVE BEEN SEEING KINKING OF THE FOLEY DRAINAGE TUBING IN DIFFERENT AREAS ALONG THE ENTIRE DRAINAGE TUBING, NOT JUST AT THE CONNECTION POINT TO THE URINE METER. THEY ALSO ATTESTED THAT THEY HAD TO KEEP A CLOSE EYE ON THE TUBING THROUGHOUT THE SHIFT. THEY NOTED THAT THIS HAD BEEN HAPPENING FOR A WHILE. CUSTOMER ALSO CHECKED WITH OPERATING ROOM AND ANESTHESIA HAD NOTICED THE KINKING ALSO. TO THEIR RECOLLECTION, IT HAD BEEN HAPPENING FOR 9-12 MONTHS. NURSE ALSO HAD BEEN SEEING KINKING AT VARIOUS POINTS OF THE DRAINAGE TUBING. THEY NOTICED THAT AS THE URINE STARTED COLLECTING IN THE TUBING, IT GOT HEAVY AND PULLS DOWN, KINKING OFF THE DRAINAGE AND CAUSED BACK UP. ON ONE SURGICAL PATIENT, NURSE THOUGHT THE PATIENT HAD A VERY LOW URINE OUTPUT, JUST TO FIND OUT AT THE END OF THE CASE THAT THE TUBING WAS KINKED UP HIGH CLOSER TO THE FOLEY CATHETER CONNECTION, THIS WAS UNDER THE STERILE DRAPE, AND THEY COULD NOT ACCESS IT UNTIL AFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034875 ↗
• MalfunctionDec 30, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT NURSE SHOWED CUSTOMER ON A CURRENT PATIENT WHERE A KINK WAS OCCURRING AT THE POINT WHERE THE DRAINAGE TUBING WAS CONNECTING TO THE URINE METER. THE STAFF HAD TO CONTINUOUSLY CHECK TO MAKE SURE IT DID NOT KINK OFF. ANOTHER NURSE NOTED THAT THEY HAVE BEEN SEEING KINKING OF THE FOLEY DRAINAGE TUBING IN DIFFERENT AREAS ALONG THE ENTIRE DRAINAGE TUBING, NOT JUST AT THE CONNECTION POINT TO THE URINE METER. THEY ALSO ATTESTED THAT THEY HAD TO KEEP A CLOSE EYE ON THE TUBING THROUGHOUT THE SHIFT. THEY NOTED THAT THIS HAD BEEN HAPPENING FOR A WHILE. CUSTOMER ALSO CHECKED WITH OPERATING ROOM AND ANESTHESIA HAD NOTICED THE KINKING ALSO. TO THEIR RECOLLECTION, IT HAD BEEN HAPPENING FOR 9-12 MONTHS. NURSE ALSO HAD BEEN SEEING KINKING AT VARIOUS POINTS OF THE DRAINAGE TUBING. THEY NOTICED THAT AS THE URINE STARTED COLLECTING IN THE TUBING, IT GOT HEAVY AND PULLS DOWN, KINKING OFF THE DRAINAGE AND CAUSED BACK UP. ON ONE SURGICAL PATIENT, NURSE THOUGHT THE PATIENT HAD A VERY LOW URINE OUTPUT, JUST TO FIND OUT AT THE END OF THE CASE THAT THE TUBING WAS KINKED UP HIGH CLOSER TO THE FOLEY CATHETER CONNECTION, THIS WAS UNDER THE STERILE DRAPE, AND THEY COULD NOT ACCESS IT UNTIL AFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034868 ↗
• MalfunctionDec 16, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT HAD A CBI RUNNING OPEN FOR HEMATURIA. THE TUBING AT THE POINT OF WHERE IT GOES INTO THE DRAIN BAG KEPT ON KINKING. THE BAG WAS REPLACED BUT THE TUBING SEEMS TO BE MORE FLEXIBLE THAN IT USED TO BE AND WITH THE HIGH PRESSURE OF THE OPEN CBI DID NOT SEEM TO TOLERATE THE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939047 ↗
• MalfunctionDec 13, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DRAIN BAG NECKS WERE PARTIALLY CLOSED AND CAUSING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924885 ↗