Bard® Urine Meter with Bag 153216Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741033186), received between Apr 18, 2017 and Jun 1, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD A BARD URINE METER WITH BAG AND SAFETY-FLOW OUTLET DEVICE WHICH HAVE MULTIPLE ISSUES WITH THESE LEAKING. AS PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6)2023, STATED THAT THE PROBLEMS HAD BEEN OCCURRING SINCE THEY TOOK DELIVERY OF THESE PRODUCTS. THEY DON¿T HAVE A BATCH NUMBER. THE LEAK OCCURRED ON THE SECOND OR THIRD EMPTY WHEN THEY FLIPPED THE HOURLY PART UP. IT SEEMS TO BE THE CLIP WAS ONLY GOOD FOR THE FIRST OR SECOND USE. IT WAS NOTICEABLE STRAIGHT AWAY AND THE CONTENTS SPILL, IT WAS NOT A SLOW LEAK. THE AFFECTED BAGS WERE NOT AVAILABLE. STATED THAT THIS WAS A SAFETY ISSUE. ENOUGH EVENTS HAD OCCURRED THAT THEIR STAFF WERE ALL SAYING THERE WAS AN ISSUE WITH THE PRODUCT. THEY HAVE HAD (PERHAPS 5) STAFF TELL THE REPRESENTATIVE THEY HAVE HAD EXPOSURE TO BODY FLUIDS FROM THE PRODUCT FAULTS. STATED THAT THEY WERE HOPING IT WAS A USER ERROR AND NOT SOMETHING THAT WAS UNIDENTIFIABLE TO HELP ALL STAFF AVOID THIS ISSUE IN THE FUTURE. THEY WERE ATTENDING THE WARD FOR PRODUCT TRAINING NEXT WEEK IN THE EVENT IT WAS USER ERROR AND THEY HAVE ASKED THEM TO KEEP THE BAG IF IT HAPPENS AGAIN SO THEY CAN COLLECT IT AND RECORD BATCH NUMBERS. IT WAS UNK

  Patient problems: Exposure to Body Fluids

  MAUDE report 17037296 ↗
• MalfunctionApr 10, 2019Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND IN THE DRAINAGE BAG PRIOR TO USE.

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

  MAUDE report 8499022 ↗
• MalfunctionOct 2, 2018Physical Resistance/Sticking

  IT WAS REPORTED THAT ONCE THE URINE WAS DRAINED, THE SUCTION CAUSED THE BAG TO STICK TOGETHER AND MADE REFILLING DIFFICULT.

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

  MAUDE report 7925336 ↗
• MalfunctionMay 4, 2018Restricted Flow rate; Restricted Flow rate; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE NON REFLUX VALVE DID NOT PREVENT URINE FROM GOING BACK UP THE TUBE WHEN EMPTYING. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 7486967 ↗
• MalfunctionMay 4, 2018Restricted Flow rate

  IT WAS REPORTED THAT DURING THE DRAINAGE OF URINE, IT REQUIRES MILKING OF THE TUBE TO GET ACCURATE MEASUREMENTS. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 7486775 ↗
• MalfunctionMar 29, 2018Restricted Flow rate; Restricted Flow rate; Improper Flow or Infusion

  IT WAS REPORTED THAT WHEN EMPTYING THE CANISTER INTO THE BAG, URINE FLOWED BACK INTO THE TUBE TOWARDS THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7380931 ↗
• MalfunctionApr 18, 2017Sticking

  IT WAS REPORTED THAT URINE ALLEGEDLY GETS STUCK IN THE CONTAINER, AND BACKS UP INTO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6501082 ↗