Bard® Uros™ Precision Urine Output and Temperature Monitor BK10001MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104947), received between May 9, 2017 and May 9, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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.

• MalfunctionMay 9, 2017Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE IN USE, THE MONITOR UNDERREPORTED, AND OVER-REPORTED THE URINE VOLUME THROUGHOUT THE DURATION OF USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555546 ↗
• MalfunctionMay 9, 2017Overfill; Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT WHILE ON A PATIENT, THE CARTRIDGE WAS ATTACHED, AND WAS OVERWHELMED BY RETAINED URINE. THE URINE BEGAN OVERFLOWING INTO THE BAG, AND THE MONITOR WAS NOT ABLE TO CYCLE FAST ENOUGH TO CAPTURE ALL OF THE RETAINED URINE. THE MONITOR OVER REPORTED AND UNDER REPORTED THE VOLUME OF URINE MULTIPLE TIMES THROUGHOUT THE DURATION OF USE. THE MONITOR ALSO BEGAN RECEIVING A TILT ALARM, ALTHOUGH THE DEVICE WAS REPORTEDLY LEVEL. THE MONITOR REMAINED ON THE PATIENT FOR THE DURATION IT WAS NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555495 ↗