Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley Tray 319114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741040009), received between Jun 15, 2022 and Oct 20, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A BLACK SPOT STAIN WAS FOUND ON THE LEFT GLOVE, SO THE HEALTH PROFESSIONAL REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337604 ↗
• MalfunctionOct 9, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY, THERE WAS NO SYRINGE INSIDE, SO THE USER REFRAINED FROM USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257351 ↗
• MalfunctionSep 22, 2025Fitting Problem; Physical Resistance/Sticking; Fitting Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING PRE-TESTING, THE VALVE MUST BE PRESSED IN WITH GREATER FORCE THAN USUAL TO DRAIN WATER FROM THE FOLEY CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 24SEP2025, STATED THAT IT SEEM THAT THE WATER COULD NOT BE REMOVED UNLESS IT WAS INSERTED WITH A LOT OF FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111830 ↗
• MalfunctionAug 26, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN THEY OPENED THE TRAY PACKAGE, THERE WAS NO LUBRICANT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895873 ↗
• MalfunctionAug 7, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT POVIDONE-IODINE WAS NOT IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737849 ↗
• MalfunctionJul 1, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED, BLACK STAINS WERE FOUND ON IT, SO THE USER STOPPED USING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371888 ↗
• MalfunctionMay 15, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY, IT WAS DISCOVERED THAT THE CONTENTS WERE MISSING. THE OTHER CONTENTS WERE DISCARDED AS THEY HAD ALREADY BEEN USED. THE PACKAGING WAS NOT COLLECTED. TRAY FORCEPS AND GAUZE WERE MISSING. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 16MAY2025, STATED THAT SESSI MEANS FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028183 ↗
• MalfunctionApr 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SYRINGE IN FOLEY TRAY WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832521 ↗
• MalfunctionMar 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN OPENED THE FOLEY TRAY STERILIZATION PACK, THERE WAS A SCREW MIXED IN. IT WAS A FOREIGN MATTER CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525808 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STERILE WATER LEAKED FROM THE VALVE OF THE SYRINGE DURING USE OF FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20492811 ↗
• MalfunctionJun 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOREIGN MATTER ADHERED TO THE SYRINGE CONTAINING STERILE DISTILLED WATER BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14698103 ↗