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

Catalog Number	010112
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient arrived for bacille calmette-guérin treatment and was prepped and used a bard #12 french urological catheter tiemann model, coude tip inserted bladder was drained, bcg placed to the hub of the catheter and began to infuse.A pin hole noted at the hub of the catheter.Immediately stopped treatment.Second catheter opened, noted pin hole, not used.Opened bard #14 coude tip, no pin hole noted.Under sterile technique, a catheter inserted and treatment given.
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.
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 due to operator or machine error that can lead bulbous tips.The labeling and instructions for use were found to be 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 required at this time.Corrections: d, e.Udi format updated with available product information per gudid.H11: sections 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 arrived for bcg [bacille calmette-guérin] treatment and was prepped and used a bard #12 french urological catheter tiemann model, coude tip inserted bladder was drained, bcg placed to the hub of the catheter and began to infuse.A pin hole noted at the hub of the catheter.Immediately stopped treatment.Second catheter opened, noted pin hole, not used.Opened bard #14 coude tip, no pin hole noted.Under sterile technique, a catheter inserted and treatment given.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: INTERMITTENT 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: 22576225
• Report Number: 1018233-2025-06047
• Device Sequence Number: 9647244
• Product Code: KOD
• UDI-Device Identifier: 00801741029851
• UDI-Public: (01)00801741029851(11)240709(17)280930(10)NGJT0049
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 010112
• Device Lot Number: NGJT0049
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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