Bardex® I.C. Complete Care® Foley Tray 900018ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741019388), received between Aug 14, 2024 and Oct 28, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Short Fill” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING, CATHETER JELLY WAS NOT INCLUDED IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403725 ↗
• MalfunctionSep 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SYRINGE OF THE FOLEY TRAY HAD A CRACK, CAUSING LEAKAGE WHEN INJECTING STERILE DISTILLED WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019226 ↗
• MalfunctionJul 24, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY, THERE WAS A STAIN ON THE GLOVE AND THE CATHETER JELLY WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588094 ↗
• MalfunctionJul 21, 2025Short Fill; Short Fill

  IT WAS REPORTED THAT STERILE DISTILLED WATER WAS NOT INCLUDED IN THE FOLEY TRAY PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555631 ↗
• MalfunctionJun 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO ADD THE FIXED WATER, THE SYRINGE WOULDN'T GO IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322192 ↗
• MalfunctionMay 30, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSPECTION OF THE FOLEY TRAY, DIRT WAS FOUND INSIDE THE BAG OF GOODS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 19MAY2025, STATED THAT WHEN RECEIVED THE ITEM, THERE WAS A LARGE STAIN ON THE INSIDE OF THE STERILIZED PACKAGING OF THE FOLEY TRAY, NOT ON THE TRAY ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114275 ↗
• MalfunctionSep 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN OBJECTS WERE OBSERVED INSIDE THE SYRINGE WHEN IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266830 ↗
• MalfunctionAug 14, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NO DISTILLED WATER IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982413 ↗