Bard® Urinary Drainage Bag 153509Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00801741029608), received between May 21, 2017 and Sep 28, 2026 — classified as 13 injuries, 78 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924421 ↗
• MalfunctionSep 21, 2026Restricted Flow rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848698 ↗
• MalfunctionAug 27, 2026Deformation Due to Compressive Stress

  It was reported that when the patient opened new package the Dome Bag hose had very tight crease on it. It was deep crease and urine would not pass through the tube that way.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485312 ↗
• MalfunctionMar 24, 2026Restricted Flow rate

  IT WAS REPORTED BY THE CUSTOMER THAT THEIR CLIENT HAD COMPLAINED ABOUT URINE FLOWING BACK INTO THE TUBING. THEY WERE UNSURE IF THIS WAS NORMAL, AS THEY BELIEVED THE TUBING SHOULD HAVE BEEN ANTI REFLUX. THE CUSTOMER HAD REQUESTED CREDITS IN THE EVENT THAT FURTHER INVESTIGATION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682772 ↗
• MalfunctionFeb 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THE TUBING WHERE IT GOES INTO THE BAG WAS BENT REALLY BAD (TWO BAGS) WOULDN'T DRAIN AND WOULDN'T STRAIGHTEN OUT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24394235 ↗
• MalfunctionSep 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOUR OF THE DRAINAGE BAGS CUSTOMERS RECEIVED HAVE DAMAGED AND DEFECTIVE TUBES. THEY HAVE PROVIDED PHOTOS WHICH HAVE BEEN UPLOADED IN THE NOTES IN OUR SYSTEM AND ARE AVAILABLE IF YOU SHOULD NEED THEM. THE PHOTOS SHOW THAT THE TUBES HAVE KINKS, CRIMPS, DENTS, AND WARPED AREAS. THEY HAVE REQUESTED REPLACEMENTS. THE CUSTOMER IS RETAINING THE FOUR ITEMS IN CASE THE MANUFACTURER REQUESTS THEM. WE HAVE ALREADY REPLACED THE PRODUCT FOR OUR CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064986 ↗
• MalfunctionSep 16, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE FOUR OF THE DRAINAGE BAGS CUSTOMER RECEIVED HAVE DAMAGED AND DEFECTIVE TUBES. THEY HAVE PROVIDED PHOTOS WHICH HAVE BEEN UPLOADED IN THE NOTES IN OUR SYSTEM, AND ARE AVAILABLE IF YOU SHOULD NEED THEM. THE PHOTOS SHOW THAT THE TUBES HAVE KINKS, CRIMPS, DENTS, AND WARPED AREAS. THEY HAVE REQUESTED REPLACEMENTS. THE CUSTOMER IS RETAINING THE FOUR ITEMS IN CASE THE MANUFACTURER REQUESTS THEM. WE HAVE ALREADY REPLACED THE PRODUCT FOR OUR CUSTOMER. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 18NOV2025, IT WAS REPORTED THAT THE SAMPLE IS NO LONGER AVAILABLE. THE ITEM WAS PURCHASED FOR A 100 YR-OLD MALE. THE PATIENT DID NOT USE THE FAULTY ITEM. THERE WAS A KINK IN THE TUBING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064977 ↗
• MalfunctionJun 30, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DRAIN BAG HAD A KINK IN THE TUBING. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357836 ↗
• MalfunctionJun 12, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CUSTOMER JUST OPENED THE DRAIN BAG, BUT IT HAD A PERMANENT KINK IN IT. CAUSED TUBE TO BE PARTIALLY CLOSED OFF PREVENTING THE URINE FROM DRAINING. ADVISED SENDING ANOTHER DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194602 ↗
• MalfunctionJun 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT SAID DRAIN BAG VALVE WAS TWISTED AND WOULD NOT FLOW PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124265 ↗
• MalfunctionJun 2, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE FOLEY CATHETER COLLAPSED INSIDE AND WOULD NOT LET URINE DRAIN. DRAINAGE TUBING CRIMP. URINE WAS BACKED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123761 ↗
• MalfunctionApr 28, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER HAD TROUBLE GETTING THE URINE TO DRAIN FROM THE URINARY DRAINAGE BAG TUBING TO BAG. REPRESENTATIVE REVIEWED POSITIONING OF BAG WITH CUSTOMER AS WELL AS VAPOR LOCK ISSUES. CUSTOMER STATED THAT THE URINE WAS BACK FLOWING INTO CATHETER WHICH THEY WERE CONCERNED ABOUT. ADVISED THE CUSTOMER THAT THEY SEEMED TO BE POSITIONING IT CORRECTLY AND ENSURED TO EXERCISE THE BAG TO PREVENT VAPOR LOCK AND THIS WOULD BE PASSED TO THEIR QUALITY DEPARTMENT FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917886 ↗
• MalfunctionApr 25, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE FLOWS BACK TO THE CATHETER AND THE URINE DID NOT DRAIN PROPERLY (EOD ON (B)(6) 2025, EOD ON (B)(6) 2025).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909290 ↗
• MalfunctionApr 25, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE FLOWS BACK TO THE CATHETER AND THE URINE DID NOT DRAIN PROPERLY (EOD-08APR2025, EOD-09APR2025).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909252 ↗
• MalfunctionApr 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DRAIN BAGS WERE LEAKING. ONE LEAKING FROM TOP, ONE LEAKING FROM BOTTOM, ONE TUBING WAS KINKED AND WOULD NOT DRAIN. THIS WAS AN ONGOING INCIDENT. CUSTOMER WOULD LIKE REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785115 ↗
• MalfunctionJan 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING IN DRAIN BAG WAS KINKED AND CANNOT BE UNKINKED, URINE BACKED UP AND GOT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217106 ↗
• MalfunctionDec 24, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE HOSE IN DRAIN BAGS HAD A KINK AND URINE WOULD NOT PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011941 ↗
• MalfunctionDec 23, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WITH COLOPLAST CONVEEN OPTIMA MALE EXTERNAL CATHETER. PATIENT USED ONLY AT NIGHT AND ADVISED THAT THE DRAINAGE BAG ONLY COLLECTS ABOUT 10% OF THE URINE AND IT LEAKED DURING THE NIGHT AND BED WAS WET WHEN THE PATIENT WAKES. PATIENT WAS UNSURE WHERE THE LEAK OCCURRED AS THE CONNECTION SEEMED TIGHT. PATIENT ADVISED THAT THEY CHANGE BAGS NIGHTLY AS DIRECTED; BAG'S LEAKING CONCERN OF THE LAST TWO SHIPMENTS AS THE URINE DOES NOT FLOW INTO THE BAG. REPRESENTATIVE CONFIRMED THAT THE CONNECTION WAS PROPERLY MADE AND REMINDED THAT IT WAS A FRICTION FIT. ADVISED THAT AN AIR LOCK MIGHT OCCUR DUE TO THE LACK OF AN AIR VENT IN THE SYSTEM. REPRESENTATIVE ASKED IF THAT HAPPENED, AGAIN THEN TO TRY SEPARATING THE SIDES OF THE BAG FROM EACH OTHER OR BLOWING AIR INTO THE (UNUSED) BAG. DOING THAT BEFORE USE MAY HELP PREVENT AN AIR LOCK FROM FORMING. IF AN AIR LOCK DOES FORM, DISCONNECT THE CATHETER FROM THE TUBING MIGHT BE NECESSARY TO ALLOW AIR INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000978 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT CUSTOMER ORDERED 7 OF THE DRAIN BAGS AND THEY STATED THAT 1 OF THEM WAS DEFECTIVE AND IT HAD A CRIMP IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988375 ↗
• InjuryAug 14, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT THOUGHT BECAUSE OF THESE DRAIN BAG DID NOT HAVE THE ANTI REFLUX CHAMBER THEY CAUSED URINARY TRACT INFECTION. IT WAS STATED THAT THE PATIENT CURRENTLY ON A ANTIBIOTIC. PER FOLLOW UP VIA PHONE ON 17SEP2024, IT WAS REPORTED REPLACEMENT BAG RECEIVED AND WORKING WELL.

  Patient problems: Urinary Tract Infection

  MAUDE report 19982242 ↗
• MalfunctionJul 22, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE DRAIN BAG HAD A KINK IN IT. PATIENT THREW IT AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792934 ↗
• MalfunctionJul 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED DEFECTIVE DRAIN BAGS WHERE THE TUBE WENT INTO THE BAG THERE WAS A BEND IN IT WHICH WAS PREVENTING IT FROM WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719227 ↗
• MalfunctionJul 9, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THREE PREVIOUS TIMES BEFORE YESTERDAY THE CUSTOMER WOULD WAKE UP AND HAVING TO USE THE BATHROOM, BUT THE ATTACHED DRAINAGE BAG WAS NOT COLLECTING URINE INITIALLY UNTIL THEY DISCONNECT TUBE FROM THE BODY, USING THE BATHROOM, AND THEN REATTACHING THEN IT WOULD WORK FOR THE REST OF THE EVENING. CUSTOMER WAS DIRECTED BY THE PHARMACY THEY PURCHASED THE ITEM FROM TO CONTACT BD'S COMPLAINT DEPARTMENT FOR FURTHER ASSISTANCE WITH THE DRAINAGE BAG ISSUE OF NOT BEING ABLE TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701210 ↗
• MalfunctionFeb 12, 2024Restricted Flow rate; Restricted Flow rate

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED BAG OR METER FAILED TO DRAIN IN RELATION TO THE URINE METER DRAIN BAG. THE NURSE INDICATED THEY BELIEVED THIS COMPLICATION TO BE A DEVICE RELATED COMPLICATION AND DIRECTLY ATTRIBUTABLE TO THE DEVICE. THE NURSE INDICATED NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685272 ↗
• InjuryFeb 9, 2024Restricted Flow rate; Restricted Flow rate

  CRITICAL CARE NURSES REPORTED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO USAGE OF BARD® LARGE-CAPACITY, CENTER-ENTRY URINE DRAINAGE BAG, 4000ML BECAUSE THE BAG OR METER FAILED TO DRAIN RESULTED IN INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION, DESCRIBED AS NA. THE TWO SURVEY IDS WERE (B)(4).

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

  MAUDE report 18677106 ↗