Bardex® I.C. Complete Care® Urine Meter Foley Tray 903014ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741019869), received between Jun 22, 2022 and Mar 25, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Difficult to Remove; Fitting Problem

  IT WAS REPORTED THERE WAS A DIFFICULTY IN DRAINING WATER FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690114 ↗
• MalfunctionNov 4, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT IN THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466904 ↗
• MalfunctionNov 4, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE SYRINGE WAS NOT INCLUDED THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466898 ↗
• MalfunctionOct 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK FOREIGN OBJECT WAS PRESENT WHEN TRAY WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357713 ↗
• MalfunctionOct 9, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND ON THE BOTTOM OF THE FOLEY TRAY. IT HAD BEEN SECURED WITH TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257348 ↗
• MalfunctionSep 12, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN OPENED, THE WATER-SOLUBLE LUBRICANT, BARD 10% POVIDONE-IODINE SOLUTION WAS NOT INCLUDED IN FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037632 ↗
• MalfunctionAug 6, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY PRODUCT THE SYRINGE CONTAINING STERILE WATER WAS NOT INCLUDED TO BEGIN WITH. HOWEVER, SINCE OTHER ITEMS WERE USABLE, THEY PREPARED AND USED STERILE WATER ON-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727589 ↗
• MalfunctionJun 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE FOLEY TRAY SYRINGE COULD NOT BE REMOVED, AND WHEN TRIED TO PULL IT OUT FORCEFULLY, THE SYRINGE BROKE OFF AT THE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327989 ↗
• MalfunctionMar 13, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A PACKAGING ISSUE FOR THE DRAIN BAG AS IT WAS OPEN AND NOT SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593708 ↗
• MalfunctionJun 22, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INLET TUBE TIP WAS DEFORMED IN WHITE AS IF MELTED JUST AFTER OPENING THE PACKAGE. THE DAMAGE WAS FOUND VISUALLY AND THE DRAIN BAG WAS NOT USED. PER FOLLOW UP VIA IBC ON 20DEC2021, THE EDGE OF THE SAMPLE PORT HAD BEEN DISCOLORED WHITE AND NEITHER BEND NOR BREAK WAS OBSERVED IN THE TIP OF THE INLET TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779199 ↗