MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER

Catalog Number	0166SI18
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
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 balloon of the foley catheter was ruptured after 1st day of placement of a catheter in the pelvis after total cystectomy.
Event or Problem Description
It was reported that the balloon of the foley catheter was ruptured after 1st day of placement of a catheter in the pelvis after total cystectomy.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Based on the evaluation, sac burst along lumen without missing piece was observed on the returned catheter.However, the exact cause of how and when the problem occurred could not be determined.A potential root cause could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ thin sac.Pfmea ra87p003 rev 22 (sac manufacturing process) was reviewed for this investigation.The failure mode is addressed in step/item # 3.A potential root cause for this potential failure mode could be due to thin sac due low latex viscosity.Based on information in the pfmea, 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.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.Correction: d, e, h 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.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• 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: 22236024
• Report Number: 1018233-2025-04513
• Device Sequence Number: 20877048
• Product Code: MJC
• UDI-Device Identifier: 00801741016851
• UDI-Public: (01)00801741016851(11)250619(17)290728(10)MYKP6510
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 0166SI18
• Device Lot Number: MYKP6510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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