Bard® Add-A-Foley Tray 399400ARecalls & reported problems
C. R. Bard, Inc. · Bard® Add-A-Foley Tray · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741024290), received between Aug 29, 2018 and Mar 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing2
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled
IT WAS REPORTED THAT PATIENT STATED 2 OUT OF 3 FOLEY TRAYS WERE OPEN AND HAD NO SOLUTION INSTEAD THEY GOT 2 LUBRICANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21594241 ↗MalfunctionAug 29, 2018Component Missing
IT WAS REPORTED THAT THE KIT WAS MISSING THE TUBING THAT CONNECTS THE DRAIN BAG TO THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7828873 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
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- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.