Bard® Foley Catheterization Tray Uro-Prep™ Tray 782100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741029622), received between Jun 19, 2018 and Feb 9, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Component Missing” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE STRAIGHT CATHETER FOLEY KIT DID NOT HAVE THE CATHETER INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11302352 ↗
• MalfunctionJul 15, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO IODINE PRESENT IN THE TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279567 ↗
• MalfunctionMay 12, 2020Component Missing

  IT WAS REPORTED THAT THE POVIDONE IODINE WAS MISSING FROM 4 TRAYS.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10048723 ↗
• MalfunctionApr 20, 2020Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE FOLEY PACKAGE WAS MISSING THE IODINE. THE END USER STATED THAT SHE HAS RECEIVED MANY PACKAGES WITHOUT THE IODINE AND NO LABEL WAS PROVIDED WITH ANY ADDITIONAL DETAILS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9977315 ↗
• MalfunctionOct 15, 2019Component Missing

  IT WAS REPORTED THAT THE IODINE WAS MISSING FROM THE KIT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9194251 ↗
• MalfunctionAug 21, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER TRAY WAS MISSING THE SYRINGE WITH STERILE WATER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8917150 ↗
• MalfunctionJul 18, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE POVIDONE-IODINE WAS MISSING FROM THE FOLEY CATH TRAY. THE COMPLAINANT REPORTEDLY HAD ADDITIONAL IODINE AVAILABLE TO USE FOR CATHETER INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804623 ↗
• MalfunctionApr 17, 2019Component Missing

  IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE CATHETER TRAY, THE POVIDONE-IODINE SOLUTION PACKET WAS MISSING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8525076 ↗
• MalfunctionMar 12, 2019Component Missing

  IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE CATHETER TRAY, THE POVIDONE-IODINE SOLUTION PACKET WAS MISSING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8412625 ↗
• MalfunctionFeb 14, 2019Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE WATER SYRINGE FROM THE FOLEY CATHETER TRAY WAS EMPTY. THE TRAY WAS STILL USED WITH SALINE INSTEAD OF WATER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8340448 ↗
• MalfunctionJan 23, 2019Component Missing

  IT WAS REPORTED THAT THE 10CC STERILE WATER SYRINGE WAS MISSING FROM THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8271048 ↗
• MalfunctionJan 7, 2019Component Missing

  IT WAS REPORTED THAT THE TRAY WAS MISSING THE IODINE SWABSTICKS. HOWEVER, PATIENT WAS ABLE TO USE REMAINDER OF KIT AS USUAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222823 ↗
• MalfunctionJun 19, 2018Component Missing

  IT WAS REPORTED THAT THE 10CC PRE-FILLED STERILE WATER SYRINGE WAS MISSING FROM THE FOLEY TRAY. IT WAS REPORTED THAT THE NURSE OPENED ANOTHER TRAY FOR A SYRINGE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7615537 ↗