Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154004Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741029585), received between Jun 20, 2017 and Sep 16, 2020 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2020Disconnection; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THAT THE CONNECTION BELOW THE PORT ON THE TUBING CAME APART IN A DRAIN BAG, WHICH RESULTED IN STERILE BREAK AND CAUSED URINARY TRACT INFECTION TO THE PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION

  Patient problems: Urinary Tract Infection

  MAUDE report 10543467 ↗
• MalfunctionMay 5, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THE TUBING ON THE DRAIN BAG KINKS AT NIGHT WHICH PREVENTS THE URINE FROM DRAINING, CAUSING IT TO GET BACKED UP INTO THE PATIENT'S STOMA BAG. THE PATIENT NOTED THAT THE DIAMETER OF THE TUBING SHOULD BE SLIGHTLY LARGER AND THAT WOULD PREVENT IT FROM KINKING.

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

  MAUDE report 10024096 ↗
• MalfunctionApr 11, 2019Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRY DATE OF THE DRAIN BAGS HAVE BEEN EXCEEDED (31MAR2017). THE COMPLAINANT WAS NOT CERTAIN OF THE EXACT TIME THE BAG WAS PURCHASED.

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

  MAUDE report 8504819 ↗
• MalfunctionApr 11, 2019Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRY DATE OF THE DRAIN BAGS HAVE BEEN EXCEEDED (31JUL2015). THE COMPLAINANT WAS NOT CERTAIN OF THE EXACT TIME THE BAG WAS PURCHASED.

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

  MAUDE report 8504815 ↗
• MalfunctionApr 11, 2019Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRY DATE OF THE DRAIN BAGS HAVE BEEN EXCEEDED (31JAN2017). THE COMPLAINANT IS UNCERTAIN OF THE EXACT TIME THE BAG WAS PURCHASED.

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

  MAUDE report 8504814 ↗
• MalfunctionApr 11, 2019Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRY DATE OF THE DRAIN BAGS HAVE BEEN EXCEEDED (28JUN2017). THE COMPLAINANT WAS NOT CERTAIN OF THE EXACT TIME THE BAG WAS PURCHASED.

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

  MAUDE report 8504679 ↗
• MalfunctionJan 3, 2019Expiration Date Error

  IT WAS REPORTED THAT THE DRAIN BAGS HAVE EXCEEDED THE EXPIRY DATE (31AUG2016). COMPLAINANT BELIEVED THE DEVICES WERE PURCHASED FROM THE HOME HEALTH AGENCY ABOUT 6-8 MONTHS AGO, HOWEVER WAS UNCERTAIN OF THE EXACT TIMELINE.

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

  MAUDE report 8213567 ↗
• InjuryAug 22, 2018Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE WHEN THE PATIENT WOKE IN THE MORNING, ABOUT 2 FEET OF URINE REMAINED IN THE DRAINAGE TUBING IN DIRECT CONTACT WITH HIS PENIS. THE COMPLAINANT STATED THAT THE TUBING HAD TO BE MANIPULATED TO GET THE URINE TO DRAIN. THE PATIENT ALLEGEDLY DEVELOPED A UTI AND EXPERIENCED BLOOD IN HIS URINE AS A RESULT. THE COMPLAINANT STATED THAT ANTIBIOTICS WERE PRESCRIBED TO TREAT THE UTI. THE DRAIN BAG WAS REPORTEDLY USED WITH A SPIRIT STYLE 3 MALE EXTERNAL CATHETER.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 7807995 ↗
• MalfunctionJan 22, 2018Obstruction of Flow; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TUBING OF THE DRAIN BAG WAS CLOGGED WITH A YELLOW, PLASTIC FOREIGN MATERIAL. THE PATIENT REPORTEDLY EXPERIENCED PAIN.

  Patient problems: Pain

  MAUDE report 7210568 ↗
• MalfunctionNov 20, 2017Bent

  IT WAS REPORTED THAT THE TUBING OF THE DRAIN BAG WAS BENT, AND RESTRICTED THE FLOW OF URINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7045382 ↗
• MalfunctionJun 28, 2017Connection Problem

  IT WAS REPORTED THAT THE TUBING DID NOT COME CONNECTED TO THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6675934 ↗
• MalfunctionJun 20, 2017Component Missing

  IT WAS REPORTED THAT THE DEVICES WERE MISSING THE DRAINAGE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654204 ↗