Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741018176), received between Jun 7, 2021 and Feb 22, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Illegible Information” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Inadequate Instructions for Healthcare Professional; Inaccurate Information; Inadequate Instructions for Healthcare Professional; Inaccurate Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF EXPIRATION DATE ERROR, ILLEGIBLE INFORMATION, INACCURATE INFORMATION, UNCLEAR INFORMATION AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO TIEMANN MODEL, LUBRICATH®, 2-WAY, 30CC BALLOON, FRENCH SIZE 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418514 ↗
• MalfunctionFeb 22, 2023Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF EXPIRATION DATE ERROR, ILLEGIBLE INFORMATION, INACCURATE INFORMATION, UNCLEAR INFORMATION AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO TIEMANN MODEL, LUBRICATH®, 2-WAY, 30CC BALLOON, FRENCH SIZE 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418509 ↗
• MalfunctionFeb 22, 2023Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF EXPIRATION DATE ERROR, ILLEGIBLE INFORMATION , INACCURATE INFORMATION, UNCLEAR INFORMATION AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO TIEMANN MODEL, LUBRICATH®, 2-WAY, 30CC BALLOON, FRENCH SIZE 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418506 ↗
• MalfunctionFeb 22, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF EXPIRATION DATE ERROR, ILLEGIBLE INFORMATION, INACCURATE INFORMATION, UNCLEAR INFORMATION AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO TIEMANN MODEL, LUBRICATH®, 2-WAY, 30CC BALLOON, FRENCH SIZE 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418050 ↗
• MalfunctionFeb 22, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE OF EXPIRATION DATE ERROR, ILLEGIBLE INFORMATION, INACCURATE INFORMATION, UNCLEAR INFORMATION AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO TIEMANN MODEL, LUBRICATH®, 2-WAY, 30CC BALLOON, FRENCH SIZE 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417036 ↗
• MalfunctionJun 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE COUDE CATHETER WAS SEVERED AND OPENED ON MID LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948220 ↗