Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray 319414ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741024429), received between Jan 9, 2019 and Jan 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2019Restricted Flow rate; No Flow; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG FROM THE TEMPERATURE SENSING FOLEY TRAY DEVELOPED A VAPOR LOCK, PREVENTING URINE FROM DRAINING INTO THE DRAIN BAG.

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

  MAUDE report 8231130 ↗