Bard® Tiemann Model Urological Catheter Coude Tip 010118Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741029882), received between May 23, 2018 and Aug 5, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150042 ↗
• MalfunctionAug 5, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150040 ↗
• MalfunctionAug 5, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150039 ↗
• MalfunctionAug 5, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150038 ↗
• MalfunctionApr 22, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED AN EMAIL COMMUNICATION REGARDING A CUSTOMER COMPLAINT. THE COMPLAINT WAS RELATED TO BARD ITEM 010118 AND INVOLVED A SPECIFIC PATIENT CONCERN STATING THAT THE PRODUCT HAD CHANGED. THE PATIENT BELIEVED THAT A DEFECTIVE PRODUCT HAD BEEN RECEIVED. IT WAS REPORTED THAT SOME OF THE CATHETERS WERE LARGER, WHICH CAUSED PAIN AND BLEEDING TO OCCUR. THE CUSTOMER HAD BEEN SEEKING GUIDANCE, AND SINCE THIS DID NOT OCCUR OFTEN, THERE WAS A REQUEST TO UNDERSTAND BARD¿S PROCEDURES REGARDING CUSTOMER PRODUCT COMPLAINTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 24958391 ↗
• MalfunctionMar 17, 2026Incorrect Measurement

  IT WAS REPORTED BY THE CUSTOMER THAT THE BARDAM COUDE CATHETER PRODUCT WAS LABELED AS EIGHTEEN FRENCH SIZE BUT APPEARED LARGER THAN THE CATHETERS PREVIOUSLY RECEIVED BY THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT COMPARED ONE CATHETER FROM EACH BOX AND REPORTED THAT ALL APPEARED LARGER. THE CUSTOMER ALSO REPORTED THAT THE PRODUCT CAUSED CUTS AND BLEEDING FOR THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s)

  MAUDE report 24621357 ↗
• MalfunctionMar 8, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A DIFFICULTY IN INSERTING THE INTERMITTENT CATHETER. IT CAUSED A ROUGH SPOT AND A SMALL AMOUNT OF BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION VIA FORM WITH SAMPLE RETURNED ON 01MAR2022, IT WAS REPORTED THAT THE CATHETER COULD NOT BE INSERTED BEYOND A FEW INCHES. ORIGINAL BARD OLIVE TIP CATHETER WERE DISCONTINUED, AND INITIAL REPLACEMENT WAS NOT LIKED AND CURRENTLY PATIENT HAD A PROPER PRODUCT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Irritability

  MAUDE report 13693029 ↗
• MalfunctionJan 10, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED TWO INTERMITTENT CATHETERS AND BOTH WERE MISSING THE MANUFACTURE INFORMATION, REFERENCE NUMBER, BARD LOT NUMBER OR SIZING SO IT COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204174 ↗
• MalfunctionDec 26, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED TWO INTERMITTENT CATHETERS AND BOTH WERE MISSING THE BARD LOT NUMBER, EXPIRATION DATE AND REFERENCE NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13085710 ↗
• MalfunctionMay 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE BARD 18 FR UROLOGICAL CATHETERS WERE TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10 BOX ORDER. THE PATIENT EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11778722 ↗
• MalfunctionMay 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE BARD 18 FR UROLOGICAL CATHETERS WERE TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10 BOX ORDER. THE PATIENT EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11778603 ↗
• MalfunctionApr 13, 2021Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE BARD 18FR UROLOGICAL CATHETER WAS TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10 BOX ORDER. THE PATIENT HAD EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11662200 ↗
• MalfunctionApr 13, 2021Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE BARD 18FR UROLOGICAL CATHETER WAS TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10-BOX ORDER. THE PATIENT HAD EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11662184 ↗
• MalfunctionApr 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE BARD 18FR UROLOGICAL CATHETER WAS TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10-BOX ORDER. THE PATIENT HAD EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11662178 ↗
• MalfunctionMar 29, 2021Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE BARD 18FR UROLOGICAL CATHETER WAS TWISTED AND THE GUIDING NIB DID NOT LINE UP WITH THE COUDE TIP. IT WAS STATED THAT IT WAS DIFFICULT TO ENSURE THE CATHETER TIP WAS POINTING UP AND THERE WERE 17 CATHETERS FROM A 10 BOX ORDER. THE PATIENT HAD EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 11581877 ↗
• MalfunctionDec 18, 2018Misassembled; Misassembled; Material Integrity Problem

  IT WAS REPORTED THAT THE DRAINAGE EYE ON THE CATHETER WAS SMALLER THAN USUAL.

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

  MAUDE report 8173364 ↗
• MalfunctionDec 18, 2018Misassembled; Misassembled; Material Integrity Problem

  IT WAS REPORTED THAT THE DRAINAGE EYE ON THE CATHETER WAS SMALLER THAN USUAL.

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

  MAUDE report 8173363 ↗
• MalfunctionMay 23, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE "CATHETER ARRIVED TWISTED IN THE PACKAGING AS A RESULT OF THE PACKAGE BEING SMALL IN SIZE."

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

  MAUDE report 7536543 ↗