MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; COUDE CATHETER

Catalog Number	010116
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the patient stated they had been using red rubber intermittent catheters, 16fr 010116 for several years.It used to be manufactured in mexico, but now it was manufactured in malaysia.Patient was not happy with the changes since manufacturing location changed.Patient stated the new catheters had a larger eyelet which seemed to get clogged easier.It also seems to have a sharper tip made insertion more difficult.Mexico manufactured lot: nggr2423.Malaysia manufactured lot: ngjw1905.Advised bd's manufacturing procedures are standardized across plants and are based upon the specific product being made.However, the products may appear slightly different.
Event or Problem Description
It was reported that the patient stated they had been using red rubber intermittent catheters, 16fr 010116 for several years.It used to be manufactured in mexico, but now it was manufactured in malaysia.Patient was not happy with the changes since manufacturing location changed.Patient stated the new catheters had a larger eyelet which seemed to get clogged easier.It also seems to had a sharper tip made insertion more difficult.Mexico manufactured lot: nggr2423.Malaysia manufactured lot: ngjw1905.Advised bd's manufacturing procedures are standardized across plants and are based upon the specific product being made.However, the products may appear slightly different.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be drainage eyes too large causing insertion difficulty.A review of the device labelling has been conducted for investigation purposes and found adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Corrections: d, h.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22496263
• Report Number: 1018233-2025-05822
• Device Sequence Number: 20986466
• Product Code: KOD
• UDI-Device Identifier: 00801741029875
• UDI-Public: (01)00801741029875(11)241023(17)281031(10)NGJW1905
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 010116
• Device Lot Number: NGJW1905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown