MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123614A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 25jan2025 the nurse placed a urinary catheter in the patient after the left ureteral stent was placed according to the doctor's instructions, in order to observe the changes in urine color, nature and volume, and provide the doctor with a basis for diagnosis and treatment.On the same day, the patient was found to had urine leakage from urethral opening and water bag joint.The nurse extracted the liquid in the water bag and found that the tube was intact.After removing the urinary catheter, the urinary catheter was re-placed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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.The potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).Pfmea (b)(4) rev 23 (sac manufacturing process) was reviewed for this investigation.The reported event is addressed in step/item # 3.A potential root cause for this failure mode could be due to blister ply (sac tearing) caused by high mechanical stability time of incoming latex.Based on information in the fmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The dhr review could not be performed without a lot number.Therefore, no additional action required at this time.This report references a us equivalent device.The us udi equivalent for this product number is used.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 on (b)(6) 2025 the nurse placed a urinary catheter in the patient after the left ureteral stent was placed according to the doctor's instructions, in order to observe the changes in urine color, nature and volume, and provide the doctor with a basis for diagnosis and treatment.On the same day, the patient was found to had urine leakage from urethral opening and water bag joint.The nurse extracted the liquid in the water bag and found that the tube was intact.After removing the urinary catheter, the urinary catheter was re-placed.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY 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: 22458425
• Report Number: 1018233-2025-05666
• Device Sequence Number: 12840998
• Product Code: KOD
• UDI-Device Identifier: 00801741095184
• UDI-Public: (01)00801741095184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: Health Professional
• Device Catalogue Number: 123614A
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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