Bardex® I.C. Complete Care® Foley Tray 900014ARecalls & reported problems
C. R. Bard, Inc. · Bardex® I.C. Complete Care® Foley Tray · Class 2
All models of Bardex I.C. Complete Care Foley Tray (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bardex I.C. Complete Care Foley Tray is a kit used to place a urinary catheter. All 82 reports describe malfunctions rather than patient harm, with no deaths and no injuries; common complaints were missing items such as the water syringe, foreign objects or contamination found in the tray, and leaking or torn gel materials. No recalls name this device. Reports dropped sharply, from 65 in the previous 12 months to 6 in the last 12.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00801741019364), received between May 14, 2022 and Dec 12, 2025 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Component Missing” (26 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.
Reports received per month
Most reported problems
Device problems
- Component Missing26
- Device Contamination with Chemical or Other Material15
- Material Fragmentation13
- Short Fill9
- Gel Leak7
- Material Split, Cut or Torn5
- Component Misassembled4
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions82
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THEY STOPPED USING THE SHEETS BECAUSE THEY FOUND A FOREIGN OBJECT ON THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796957 ↗MalfunctionDec 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING FOLEY CATHETER PLACEMENT FOR URINARY DRAINAGE IN THE WARD, THE STERILE GLOVES WERE CONTAMINATED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700461 ↗MalfunctionNov 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT WHEN ATTEMPTING TO USE FOLEY TRAY ON A PATIENT, THE USER NOTICED A FOREIGN OBJECT ATTACHED TO THE COTTON BALL AND DISCONTINUED USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616990 ↗MalfunctionNov 5, 2025Component Missing; Component Missing
IT WAS REPORTED THAT, BEFORE USE IT WAS FOUND SYRINGE CONTAINING STERILE WATER WAS MISSING IN FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478301 ↗MalfunctionNov 3, 2025Missing Information; Missing Information
IT WAS REPORTED THAT USE OF A LATEX FOLEY CATHETER IN LATEX-ALLERGIC PATIENTS DUE TO THE ABSENCE OF LATEX LABELING IN THE LEAFLET. AN INCIDENT OCCURRED IN THE HOSPITAL WHERE A LATEX CATHETER WAS USED ON A PATIENT WITH A LATEX ALLERGY BECAUSE THE TRAYS PRODUCT LEAFLET DID NOT INDICATE THE PRESENCE OF LATEX. THE PATIENT DID NOT EXPERIENCE ANY ALLERGIC REACTION AND THERE WERE NO PARTICULAR PROBLEMS. THE DEPUTY HEAD NURSE, WHO REPORTED THIS COMPLAINT, IS QUESTIONING WHY THE MEDICON PRODUCT¿S LEAFLET DOES NOT INDICATE LATEX, AS MOST OTHER MANUFACTURERS' LATEX PRODUCTS TYPICALLY INCLUDE LATEX LABELING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23455499 ↗MalfunctionNov 3, 2025Component Missing; Component Missing
IT WAS REPORTED THAT WHEN OPENED THE FOLEY TRAY BEFORE USE, THERE WAS NO LUBRICATING JELLY OR DISINFECTANT INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452644 ↗MalfunctionOct 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE PRE-TEST, IT WAS DIFFICULT TO DRAIN THE WATER FROM THE CATHETER, DUE TO THE SYRINGE COULD NOT BE PULLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438155 ↗MalfunctionOct 28, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING PRE-TESTING, WHEN THEY CONNECTED THE SYRINGE TO THE INFLATION VALVE AND TRIED TO INJECT WATER INTO THE BALLOON, THE SYRINGE BECAME STUCK. SYRINGE CONNECTION WAS POOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405649 ↗MalfunctionOct 28, 2025Component Missing; Component Missing
IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED ON (B)(6) 2025. THE CATHETER WAS NATURALLY REMOVED THE FOLLOWING DAY, THE (B)(6) 2025. ALSO, IT WAS FOUND NO LEAFLET WAS PRESENT IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402695 ↗MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WERE IMPURITIES IN THE CATHETER JELLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393984 ↗MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER OPENING THE FOLEY CATHETER WAS FOREIGN OBJECT INSIDE THE GLOVE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393256 ↗MalfunctionOct 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT USE WAS DISCONTINUED DUE TO HAIR BEING FOUND IN THE FOLEY TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23382241 ↗MalfunctionOct 21, 2025Component Missing; Component Missing
IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY IT WAS DISCOVERED THAT THE SYRINGE WAS NOT INCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349367 ↗MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE FOLEY TRAY WAS OPENED IT WAS FOUND THAT THE JELLY'S PACKAGING WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279226 ↗MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER OPENING THE FOLEY TRAY, THE GLOVES WERE FOUND TO BE DIRTY, SO THE USE WAS DISCONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278922 ↗MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE FOLEY TRAY GLOVES WERE DIRTY AFTER OPENING, SO THEIR USE WAS DISCONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278035 ↗MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, FOREIGN MATTER WAS FOUND INSIDE THE FOLEY TRAY, SO USE WAS DISCONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277999 ↗MalfunctionOct 15, 2025Material Fragmentation; Melted; Material Puncture/Hole; Material Fragmentation; Melted; Material Puncture/Hole
IT WAS REPORTED THAT UPON OPENING, A SIGNIFICANT AMOUNT OF STERILE WATER LEAKED OUT FROM THE TIP OF THE FOLEY CATHETER, SO THE HEALTH PROFESSIONAL REFRAINED FROM USING IT. PER CLARIFICATION INFORMATION RECEIVED VIA EMAIL ON 22JAN2026, IT WAS REPORTED ISSUE WAS THAT THE DAMAGE OF THE SYRINGE RESULTING IN LEAKAGE. SO, NOT DEFLATION DUE TO TRAUMA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277879 ↗MalfunctionOct 10, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY, IT WAS DISCOVERED THAT THE JELLY HAD LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23268589 ↗MalfunctionOct 10, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT HAIR IN THE SHEETS. THEY OPENED THE SHEETS AND FOUND A HAIR IN THEM. THEY PUT A STICKY NOTE ON IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23266305 ↗MalfunctionOct 7, 2025Component Missing; Component Missing
IT WAS REPORTED THAT BEFORE USE THERE WAS NO JELLY WHEN THE USER USED THE FOLEY TRAY IN THE EMERGENCY ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23240040 ↗MalfunctionSep 25, 2025Gel Leak; Gel Leak
IT WAS REPORTED THAT AFTER OPENING THE TRAY IT WAS FOUND THE AREA CONTAINING THE DISINFECTANT SOLUTION AND LUBRICATING JELLY INSIDE THE TRAY WAS WET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23144770 ↗MalfunctionSep 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THEY OPENED THE FOLEY TRAY, THE CATHETER JELLY WAS TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23111147 ↗MalfunctionSep 18, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE FOLEY TRAY SYRINGE WAS NOT INCLUDED. IT SEEMS THAT THEY REALIZED THE SYRINGE WAS MISSING DURING THE INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083739 ↗MalfunctionSep 15, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THERE WAS NO SYRINGE IN THE FOLEY TRAY KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23053264 ↗
Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3,889 reports
- Bardex® I.C. Foley Catheter 0165SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 reports
- Bardex® I.C. Foley Catheter 0165SI16C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® I.C. Temperature Sensing Foley Catheter 129414MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119316MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES231 reports
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES198 reports
- Bardex® I.C. Foley Catheter 0165SI18C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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