Bard® Urethral Catheterization Tray with Vinyl Catheter 772417Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741030437), received between Jul 26, 2017 and May 9, 2022 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Component Missing” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE URETHERAL CATHETER TRAY HAD THE STERILE GLOVES LOCATED UNDER THE DRAPE WHICH AS A RESULT ONE WAS UNABLE TO STERIALLY PLACE THE DRAPE UNLESS THE NURSE GRABBED OWN SET OF GLOVES (MATERIAL# 772414-LOT# (B)(4). CUSTOMER HAD THREE TRAYS THAT HAVE BEEN LIKE THIS SO FAR THE WAY IT WAS PACKAGED (MATERIAL# 772417-LOT# UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336926 ↗
• MalfunctionJul 12, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CATHETER INSIDE THE STRAIGHT CATHETER PACKAGE UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154481 ↗
• MalfunctionMar 19, 2020Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM SOME OF THE KITS.

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

  MAUDE report 9855638 ↗
• MalfunctionFeb 19, 2020Defective Device; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CATHETER HAD A WHITE FIBER IN THE HOLES OF THE CATHETER AT THE INSERTION END BEFORE USE.

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

  MAUDE report 9729651 ↗
• MalfunctionDec 17, 2019Component Missing; Packaging Problem

  IT WAS REPORTED THAT THE WRONG PRODUCT WAS IN THE PACKAGE. THE CUSTOMER WAS MISSING IODINE. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2019, THE CUSTOMER CONFIRMED THAT THERE WAS NOT AN INCORRECT DEVICE IN THE PACKAGE, THE IODINE WAS MISSING FROM THE PACKAGE.

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

  MAUDE report 9481228 ↗
• MalfunctionDec 10, 2019Component Missing

  IT WAS REPORTED THAT THE KIT WAS MISSING IODINE.

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

  MAUDE report 9447487 ↗
• MalfunctionDec 10, 2019Component Missing

  IT WAS REPORTED THAT THE KIT WAS MISSING TWEEZERS, IODINE, AND COTTON SWABS.

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

  MAUDE report 9447486 ↗
• MalfunctionSep 27, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 9129674 ↗
• MalfunctionJun 19, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT THE KIT STATED IT CONTAINED THREE IODINE SWAB STICKS. ONCE OPENED; IT WAS NOTED THAT THE KIT CONTAINED COTTON BALLS AND TONGS AND DID NOT INCLUDE THE LIQUID IODINE. PER REVIEW OF THE CATALOG, COTTON BALLS ARE NOT INCLUDED IN THE CONTENTS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8713773 ↗
• MalfunctionJun 13, 2019Component Missing

  IT WAS REPORTED THAT THE URETHRAL CATHETER TRAY WAS MISSING THE IODINE SWABSTICKS; THERE WAS NO YELLOW WARNING STICKER ON THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696489 ↗
• MalfunctionJun 5, 2019Component Missing

  IT WAS REPORTED THAT THE PVI WAS MISSING FROM THE URETHRAL CATHETER TRAY. THE CUSTOMER ALSO NOTED THAT COTTON BALLS WERE ALSO MISSING FROM THE TRAY, HOWEVER, PER REVIEW OF THE CATALOG, COTTON BALLS ARE NOT INCLUDED IN THE CONTENTS.

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

  MAUDE report 8671518 ↗
• MalfunctionMay 3, 2019Incorrect Measurement; Misassembled; Misassembled

  IT WAS REPORTED THAT THE STRAIGHT CATHETER KIT BASIN MEASURED 150-200 ML MORE THAN A GRADUATED CYLINDER. THE MARKINGS WERE THERE; HOWEVER THE TECHNICIAN SAID THAT THE MARKINGS WERE OFF CENTERED BEING THE REASON FOR THE INCONSISTENT MEASUREMENTS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8579100 ↗
• MalfunctionMar 25, 2019Component Missing

  IT WAS REPORTED THAT THE KIT DID NOT CONTAIN ANY COMPONENTS OTHER THAN THE CATHETER. THE CUSTOMER ALLEGED THAT THE IODINE, UNDER PAD, DRAPE, SPECIMEN CONTAINER, SWAB STICKS, AND LUBRICANT WERE MISSING.

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

  MAUDE report 8449786 ↗
• MalfunctionFeb 6, 2019Component Missing; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PVI SWABSTICKS WERE MISSING FROM THE TRAY. REPORTEDLY, THERE WAS NO YELLOW STICKER ON THE PACKAGING INDICATING THAT THE STICKS WERE NOT IN THEY TRAY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8309889 ↗
• MalfunctionJan 31, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER TRAY WAS MISSING COTTON BALLS, LUBRICANT AND TONGS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292272 ↗
• MalfunctionJan 9, 2019Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

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

  MAUDE report 8231521 ↗
• MalfunctionOct 31, 2018Component Missing

  IT WAS REPORTED THAT THERE WAS A MISSING CATHETER AND RAYON BALLS FROM THE CATHETER TRAY PRIOR TO USE.

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

  MAUDE report 8026183 ↗
• MalfunctionSep 17, 2018Component Missing

  IT WAS REPORTED THAT THE URETHRAL TRAY DID NOT CONTAIN A CATHETER. NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 7882618 ↗
• MalfunctionJul 26, 2017Component Missing

  IT WAS REPORTED THAT THE CATHETER KIT DID NOT CONTAIN A CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 6745607 ↗