Bard® Urethral Catheterization Tray with Plastic Catheter 771114Recalls & reported problems
C. R. Bard, Inc. · Bard® Urethral Catheterization Tray with Plastic Catheter · Class 2
All models of Bard Urethral Catheterization Tray with Plastic Catheter (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00801741030482), received between Oct 13, 2020 and Jul 21, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
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
Device problems
- Component Misassembled1
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2022Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE CATHETER IN THE URETHRAL CATHETERIZATION TRAY WAS SEALED SHUT ON THE END AND THEY HAD TO WASTE THAT PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073721 ↗MalfunctionOct 13, 2020Component Missing; Component Missing
IT WAS REPORTED THAT THE YELLOW STICKER ON THE URETHRAL CATHETERIZATION KIT STATES THAT THERE WERE NO STERILE GLOVES IN THE PACKAGE. THERE WAS NO MENTION OF THE LUBRICANT, AND CERTAINLY THE ISSUE OF THE CATHETER DETACHED FROM THE BAG SO EASILY WAS CONCERNING.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10671433 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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