Bardex® I.C. Complete Care® Urine Meter Foley Tray 303014ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741019913), received between Aug 14, 2024 and Mar 11, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Short Fill” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Wrong Label

  IT WAS REPORTED THAT DURING THE PRE-TEST, WATER COULD BE INTRODUCED BUT NOT DRAINED. ALSO, IT'S A 773 (LATEX) BUT FOR SOME REASON THERE IS A 6630 (SIILCONE) CATHETER ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572171 ↗
• MalfunctionOct 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, AFTER OPENING, FOREIGN MATTER FOUND IN THE FOLEY TRAY AS IT WAS NOT SEALED IN A SMALL BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416400 ↗
• MalfunctionOct 28, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT BEFORE USE THE WATER-BASED LUBRICANT BROKE AND LEAKED INTO THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404916 ↗
• MalfunctionOct 28, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WAS A SYRINGE TROUBLE DUE TO THIS WATER DID NOT DRAIN FROM THE FOLEY CATHETER DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404746 ↗
• MalfunctionSep 26, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED AND THE PATIENT WAS ABOUT TO BEGIN USING THE PRODUCT, IT HAD TO DISCONTINUE TO USE DUE TO A SHORTAGE OF SYRINGES FILLED WITH STERILE WATER. THERE WAS A SHORTAGE OF 10MM SYRINGES FILLED WITH STERILE WATER. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26AUG2025, STATED THAT STERILE WATER IN THE SYRINGE WAS NOT ENOUGH. AS PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 03SEP2025, STATED THAT SYRINGE HAD BEEN LOST AND MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154632 ↗
• MalfunctionJul 25, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT, AFTER OPENING THE TRAY, THERE WAS NO SYRINGE INSIDE THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609423 ↗
• MalfunctionJul 2, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE USER LOOKED AT THE FOLEY TRAY FROM THE OUTSIDE BEFORE OPENING IT, THE OUTER PACKAGING WAS TORN, SO THE PRODUCT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383757 ↗
• MalfunctionMay 30, 2025Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn; Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE PATIENT OPENED THE FOLEY TRAY PACKAGE AND WAS ABOUT TO BEGIN USING IT, THE CLINIC STAFF NOTICED THAT THE PACKAGING PAPER WAS TORN AND DISCONTINUED USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113610 ↗
• MalfunctionMar 24, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FOLEY TRAY PACKAGE WAS DAMAGED THERE WAS HOLE IN THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677837 ↗
• MalfunctionDec 24, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT POVIDONE-IODINE WAS LEAKING IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011191 ↗
• MalfunctionSep 12, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT THE AFTER OPENING THE FOLEY TRAY KIT PRODUCT. WHEN THEY TOUCHED THE BAG OF LUBRICATING JELLY, IT FELT LIKE THERE WAS NOTHING INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200007 ↗
• MalfunctionSep 11, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT AFTER OPENING THE PRODUCT A SINGLE PACKAGE OF FOLEY TRAY CATHETER JELLY, THERE WAS NO CONTENT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189278 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Short Fill; Material Fragmentation; Short Fill

  IT WAS REPORTED THAT THE SYRINGE IN THE FOLEY TRAY WAS DEFECTIVE WHERE THE SYRINGE CAP WAS DEFECTIVE AND WAS LEAKING. THE CAP WAS NOT SECURELY ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025536 ↗
• MalfunctionAug 14, 2024Short Fill; Component Missing; Short Fill; Component Missing

  IT WAS REPORTED THAT WHEN THE CATHETER WAS OPENED IN THE OPERATING ROOM TO PLACE FOR URINARY DRAINAGE, THERE WAS NO CATHETER JELLY CONTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982271 ↗