Bard® Large-Capacity Urinary Drainage Bag 253509ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741029578), received between Aug 8, 2018 and Dec 19, 2019 — classified as 1 injury, 1 malfunction.

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

• InjuryDec 19, 2019Restricted Flow rate; Backflow; Break; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT STATED THE URINE WAS GOING BACK INTO THE TUBE. HE STATED THAT IT HAD CAUSED HIM AN INFECTION. HE ASKED FOR A BIGGER BAG OR ONE THAT HAD A FLOATING BALL TO STOP THE REFLUX. HE ALSO STATED THAT ONLY THE BAG HAD BROKEN AT THE SEAM. NO MEDICAL INTERVENTION REPORTED. IT WAS LATER REPORTED FROM THE CUSTOMER VIA PHONE ON 19DEC2019, HE EXPERIENCED A BURNING SENSATION ALONG WITH THE URINARY TRACT INFECTION. THE CUSTOMER NOTED THAT THE UTI WAS TREATED WITH PRESCRIBED ANTIBIOTICS.

  Patient problems: Burning Sensation; Urinary Tract Infection

  MAUDE report 9498511 ↗
• MalfunctionAug 8, 2018Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE URINE WOULD NOT DRAIN INTO THE DRAINAGE BAG. ALLEGEDLY THE PATIENT EXPERIENCED A HURTING BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7763818 ↗