Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741029516), received between May 23, 2018 and Feb 5, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Partial Blockage; Partial Blockage

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THEY WERE NOT ABLE TO SUCCESSFULLY COLLECT URINE BECAUSE IT WAS BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641843 ↗
• MalfunctionAug 10, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WAS NOT WORKING. STATED THAT THE TUBE BACKFLOWS AND FILLED UP AND DID NOT EMPTY ONTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199069 ↗
• MalfunctionAug 18, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WAS NOT DRAINING FROM THE CHAMBER AND BACKS UP INTO THE TUBING. THE CUSTOMER WAS NOTICED THIS ISSUE OCCURRED PREVIOUSLY BUT DID NOT REPORTED TO BD, ONLY TO THE NURSE. THE PRODUCT WAS USED BY PATIENT CURRENTLY BUT CREATING A PROBLEM WITH BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337201 ↗
• MalfunctionMar 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS CURLED UP AND TWISTED UP AND USER FELT UNCOMFORTABLE TO PULL OUT FROM VAGINA. CUSTOMER BELIEVED, ISSUE WAS FROM THE MANUFACTURING PLANT AND THE WAY IT WAS PACKED. IT WAS STATED THAT CARD WAS ALL TWISTED AND THE CUSTOMER NEED THE CATHETER TO BE ANOTHER SIX INCHES OF LENGTH. CUSTOMER WAS FRUSTRATED AND HAS BEEN IN CONTACT WITH FOUR DIFFERENT CUSTOMER SUPPORT NUMBERS AND THE ISSUE HAS NOT BEEN RESOLVED AND CUSTOMER EXPERIENCED UNCOMFORTABLE FOR MONTHS. PER FOLLOW-UP FROM CUSTOMER VIA PHONE ON (B)(6) 2021, CUSTOMER STATED THERE WAS NO PROBLEM WITH THE FOLEY CATHETER. THE CLEAR TUBING TURNED FROM THE CATHETER TO THE BAG DID NOT LAY FLAT AND WAS IN A CIRCLE. CUSTOMER ALSO NOTED THAT IT WAS NOT TWISTED BUT JUST CURLED UP IN CIRCLE AND HAD TO MANIPULATE THE TUBING TO GET URINE TO FLOW INTO THE BAG BECAUSE THE TUBING WAS NOT STRAIGHT. ALSO ADDED THAT THE SAMPLE PORT CONNECTOR PUSHED INTO THE PATIENT¿S LEG AND MAKE SCRATCH WHICH CAUSED PAIN. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Abrasion; Discomfort; Pain

  MAUDE report 11510073 ↗
• MalfunctionOct 9, 2020Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINARY DRAINAGE BAGS WERE NOT DRAINING CORRECTLY. THE EVENT OCCURRED 2 WEEKS AGO AND ALSO ON (B)(6) 2020. PER FOLLOW UP VIA PHONE ON 24SEP2020 THE CAREGIVER EMPTIED THE BAG AND AFTER THE BAG WAS EMPTIED THE SIDES STUCK TOGETHER AND DID NOT ALLOW ANY MORE URINE TO DRAIN INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10658886 ↗
• MalfunctionOct 9, 2020Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE URINARY DRAINAGE BAGS WERE NOT DRAINING CORRECTLY. THE EVENT OCCURRED 2 WEEKS AGO AND ALSO ON (B)(6) 2020. PER FOLLOW UP VIA PHONE ON 24SEP2020 THE CAREGIVER EMPTIED THE BAG AND AFTER THE BAG WAS EMPTIED THE SIDES STUCK TOGETHER AND DID NOT ALLOW ANY MORE URINE TO DRAIN INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10658872 ↗
• InjuryJul 25, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION FOLLOWING USE OF THE DRAIN BAG. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7718560 ↗
• MalfunctionMay 23, 2018Fungus in Device Environment; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT MOLD WAS OBSERVED IN THE DRAIN BAG AFTER 2 DAYS OF USE.

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

  MAUDE report 7537036 ↗