Bard® Urinary Drainage Bag 154114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741029547), received between Dec 20, 2017 and Feb 20, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Disconnection

  IT WAS REPORTED THAT THE SAMPLE PORT FELL OUT OF CLOSED SYSTEM DRAIN BAG. A SPECIMEN PORT SPONTANEOUSLY FELL OUT OF THE SYSTEM'S DRAINAGE TUBING, RESULTING IN AN OPEN SYSTEM, AND REQUIRING A REINSERTION. CUSTOMER ALSO ATTACHED AN IMAGE BELOW SHOWING THE BLUE SPECIMEN/SAMPLE PORT HAVING SPONTANEOUSLY FELL OUT. STAFF REPORTED THEY DID NOT MANIPULATE THE PORT IN ANY WAY PRIOR TO FINDING IT LIKE THIS. IN THE IMAGE YOU CAN JUST MAKE OUT HOW THE STAFF FOUND THE DEVICE WITH THE BLUE VALVE SEPARATE FROM THE CATHETER DRAINAGE TUBING. CUSTOMER USED A STANDARD FOLEY DRAINAGE BAG. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 04FEB2026, IT WAS REPORTED THAT THE SOME OF THE LOT/SN INFORMATION HAD WORN/RUBBED OFF AND I WAS AND STILL AM UNABLE TO DECIPHER. THERE WAS PATIENT IMPACT RELATED TO THE USE OF THIS DEVICE AND THE MEDICAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. THE FOLEY HAD TO BE REMOVED. NO TROUBLESHOOTING WAS ATTEMPTED, THE SYSTEM WAS OPEN AND THE SPECIMEN PORT THAT ¿FELL OUT¿ AS CONTAMINATED AT THAT POINT, SO THE FOLEY HAD TO BE REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24408100 ↗
• MalfunctionNov 25, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT IN OR DEPARTMENT, INSERTED ONE OF THESE FOLEY CATHETERS IN A PATIENT AND COULD NOT GET THE BALLOON TO INFLATE. THEY OPENED A 2ND TRAY AND HAD THE SAME ISSUE WITH THAT TRAY. THEY DID NOT KEEP ANY OF THE USED CATHETERS. THEY ONLY HAVE THE OUTER PACKAGES, BUT THEY DO NOT HAVE THE LOT NUMBERS ON THE OUTER PACKAGING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 17NOV2025, IT WAS REPORTED THAT THEY HAVE THE OUTER WRAPPERS FOR THE 2 FOLEY TRAYS, BUT UNFORTUNATELY THE STAFF DID NOT RETAIN THE DEFECTIVE CATHETERS. LOT NUMBER WAS NOT AVAILABLE. TWO URINARY CATHETER INSERTIONS WERE REQUIRED. REMOVAL AND REINSERTION OF URINARY CATHETER WERE PERFORMED. THEY WERE PERFORMED TROUBLESHOOTING. ATTEMPTED TO INSERT A FOLEY AND THE BALLOON WOULD NOT INFLATE. FOLEY REMOVED. OPENED ANOTHER FOLEY KIT AND WHILE TESTING THE BALLOON A LEAK WAS SEEN, AND THIS BALLOON WOULD ALSO NOT INFLATE. OPENED ANOTHER FOLEY KIT, BALLOON TESTED AND INFLATED APPROPRIATELY. FOLEY INSERTED AND THEN UNABLE TO DRAW URINE FROM THE PORT WITH SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645913 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD A TEAR UPON OPENING AND REFRAINED FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409941 ↗
• MalfunctionDec 2, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE INFECTION CONTROL URINARY DRAINAGE BAG WOULD NOT EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825065 ↗
• MalfunctionMay 10, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT TWICE IN THE LAST WEEK A FOLEY DRAINAGE BAG WOULD NOT DRAIN WHEN THE NURSE UNCLAMPED THE FOLEY TO DRAIN THE BAG. THE NURSE ATTEMPTED TO FLUSH THE GREEN DRAINAGE TUBE WHERE THE CLAMP LIED, BUT IT WOULD NOT FLUSH. IT WAS DISCOVERED IN TWO INSTANCES THAT THE DRAINAGE BAG WAS SEALED TO ITSELF, THUS NOT DRAINING. WHEN THE NURSE TRIED TO PEEL THE DRAINAGE BAG SIDES AWAY FROM EACH OTHER, THE BAG SPRUNG A LEAK AND LEAKED URINE. (LOT# UNK - 154114A) (LOT# NGHV0244 - 153204)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285351 ↗
• MalfunctionNov 10, 2023Incorrect Measurement; Nonstandard Device; Incorrect Measurement; Nonstandard Device

  IT WAS REPORTED THAT IN (B)(6) 2021 BARD UNIVERSAL CATHETERIZATION TRAY WAS DISCONTINUED (LAWSON # 227022, REF 792100) AND WAS REPLACED WITH THE ITEM LISTED ABOVE. UROLOGY STAFF'S MAIN CONCERN WAS WHEN THE CATHETER WAS INSERTED, BEFORE HOOKING THE DRAINAGE BAG TUBING, THEY ENSURE URINE FLOW. THE CONTAINER WAS TOO LARGE AND SQUARE AND COULD NOT ADEQUATELY COLLECT URINE. THEY IMPROVISED BY USING A CLEAN GRADUATED CYLINDER BREAKING STERILITY. ANOTHER BARD CATHETERIZATION ITEM (LAWSON # 317827) WAS USED ON SOME UNITS IN THE REGION. CLINIC STAFF SAID THIS CONTAINER HAD SIMILAR PROBLEMS AS THE ONES THEY CURRENTLY STOCK. THE REQUEST FROM END USER STAFF FOR THE COLLECTION TRAY TO MIMIC THE OLD DISCONTINUED ITEM, SIMILAR TO THE KIT OF AN I/O CATHETER TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110346 ↗
• MalfunctionNov 10, 2023Incorrect Measurement; Nonstandard Device; Incorrect Measurement; Nonstandard Device

  IT WAS REPORTED THAT IN (B)(6) 2021 BARD UNIVERSAL CATHETERIZATION TRAY WAS DISCONTINUED (LAWSON # 227022, REF 792100) AND WAS REPLACED WITH THE ITEM LISTED ABOVE. UROLOGY STAFF'S MAIN CONCERN WAS WHEN THE CATHETER WAS INSERTED, BEFORE HOOKING THE DRAINAGE BAG TUBING, THEY ENSURE URINE FLOW. THE CONTAINER WAS TOO LARGE AND SQUARE AND COULD NOT ADEQUATELY COLLECT URINE. THEY IMPROVISED BY USING A CLEAN GRADUATED CYLINDER BREAKING STERILITY. ANOTHER BARD CATHETERIZATION ITEM (LAWSON # 317827) WAS USED ON SOME UNITS IN THE REGION. CLINIC STAFF SAID THIS CONTAINER HAD SIMILAR PROBLEMS AS THE ONES THEY CURRENTLY STOCK. THE REQUEST FROM END USER STAFF FOR THE COLLECTION TRAY TO MIMIC THE OLD DISCONTINUED ITEM, SIMILAR TO THE KIT OF AN I/O CATHETER TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110345 ↗
• MalfunctionMar 13, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE URINARY DRAINAGE BAG HAD A HARD TIME IRRIGATING BLADDERS POSTOPERATIVELY AND CLOTS ARE GETTING CAUGHT IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529129 ↗
• InjuryOct 25, 2018Patient-Device Incompatibility; Leak/Splash; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AN INFECTION AND WAS PRESCRIBED ANTIBIOTICS DURING USE OF THE DRAIN BAG. THE DRAIN BAG LEAKED FROM THE CONNECTION BETWEEN THE INLET TUBE AND THE SAMPLE PORT CONNECTOR, AS A RESULT THE PATIENT ALLEGEDLY EXPERIENCED AN INFECTION DUE THE LEAKING BAG. THE DRAIN BAG WAS PLACED BY THE HOME HEALTH NURSE. GAUZE WAS WRAPPED AROUND THE CONNECTOR WHERE THE BAG WAS LEAKING UNTIL THE DRAIN BAG COULD BE CHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 8004335 ↗
• MalfunctionDec 20, 2017Hole In Material; Component Missing

  IT WAS REPORTED THAT WHEN UNCLAMPING A FOLEY CATHETER ON A PATIENT WITH A MITOMYCIN BLADDER INSTILLATION, THE DRAINAGE BAG TUBING HAD A HOLE IN IT, WHERE THE PURPLE PORT PLUG WAS MISSING. THIS ALLOWED MITOMYCIN TO DRAIN ONTO THE PATIENT'S LEFT LEG AND LINENS. THIS EVENT RESULTED IN A CHEMOTHERAPY EXPOSURE AND SPILL, BUT DID NOT CAUSE THE PATIENT OR EMPLOYEE HARM. THE DRAINAGE BAG HAD BEEN PLACED ON THE DAY OF THE EVENT. CLINICAL STATEMENT: THE MITOMYCIN IS AN ANTINEOPLASTIC DRUG USED FOR CANCER. THE DRUG IS INSERTED INTO THE BLADDER VIA THE CATHETER AND THE CATHETER CLAMPED FOR SEVERAL HOURS. THEN, THE CLAMP IS UNDONE FOR THE URINE AND DRUG TO BE DRAINED. THERE WAS NOT ANY HARM DONE TO THE PATIENT OR EMPLOYEE. THE COMPLAINT IS BEING REPORTED FOR THE POTENTIAL OF INJURY. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133042 ↗