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

Catalog Number	123616A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
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.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, the patient underwent routine urinary catheterization following cervical cancer surgery.On the first postoperative day at noon, during vaginal cleansing, the nurse discovered the balloon of the foley catheter had detached.Examination revealed a 3cm tear in the balloon.The incident was immediately reported to the attending physician, and the catheter was replaced with a disposable one.The patient experienced no adverse effects.
Event or Problem Description
It was reported that, the patient underwent routine urinary catheterization following cervical cancer surgery.On the first postoperative day at noon, during vaginal cleansing, the nurse discovered the balloon of the foley catheter had detached.Examination revealed a 3cm tear in the balloon.The incident was immediately reported to the attending physician, and the catheter was replaced with a disposable one.The patient experienced no adverse effects.
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.A potential root cause for this failure could be for this failure mode could be user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).A potential root cause for this failure mode could be due to thin sac causing by short latex dwell time, latex dip speed out too slow.Based on information in the fmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.A review of the device labelling has been conducted for investigation purposed.The ifu is attached in the investigation overview tab.The labeling and instructions for use were found to be adequate.This report references a us equivalent device.The us udi equivalent for this product number is used.Correction: d.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.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.

• 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: 23123092
• Report Number: 1018233-2025-08468
• Device Sequence Number: 9287544
• Product Code: KOD
• UDI-Device Identifier: 00801741095191
• UDI-Public: (01)00801741095191(11)240923(17)290528(10)MYJV1154
• 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): 10/10/2025

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: 123616A
• Device Lot Number: MYJV1154
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2024
• 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