Bard® Urinary Drainage Bag 154005ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741029561), received between Jun 28, 2018 and Mar 19, 2020 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2020Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG WOULDN¿T DRAIN. THE CUSTOMER REPORTEDLY ATTEMPTED TO REPOSITION, FLUSH, ETC., AND ENDED UP HAVING TO CHANGE IT OUT.

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

  MAUDE report 9853530 ↗
• MalfunctionDec 13, 2018Restricted Flow rate; Restricted Flow rate; Fluid/Blood Leak

  IT WAS REPORTED THAT THE URINE APPEARED TO BACK UP IN THE TUBING CREATING A LEAK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8161730 ↗
• InjuryJun 28, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABRASIONS ON HIS FINGERS AND HANDS FROM THE METAL CLASP ON THE BAG. THE PATIENT REPORTEDLY EXPERIENCED INFECTIONS IN HIS HANDS FOLLOWING THE ABRASIONS AND WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION.

  Patient problems: Abrasion; Unspecified Infection

  MAUDE report 7647798 ↗