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

Catalog Number	123520A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the a few days after placement, the foley catheter balloon was broken and was removed spontaneously.They had not received any reports of anything being left inside the body.
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 a few days after placement, the foley catheter balloon was broken and was removed spontaneously.They had not received any reports of anything being left inside the body.
Additional Manufacturer Narrative
The reported event was confirmed - cause unknown.The product had caused the reported failure.Visual inspection noted irregular burst without missing pieces.Introduced water into the inflation lumen and did not experience any obstructions to impede flow.Microscopic examination found there was present salt on the balloon area.However, the exact cause on how and when problem occurred could not be determined.The potential root cause for this failure 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 could be contribute by high mechanical stability time (mst) of incoming latex or coagulant dip 2- dipping speed 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 labeling has been conducted for investigation purposed.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 is required at this time.Corrections: d, e, h 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.

• 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: 22089400
• Report Number: 1018233-2025-03904
• Device Sequence Number: 18148255
• Product Code: EZC
• UDI-Device Identifier: 00801741095115
• UDI-Public: (01)00801741095115(11)241218(17)290828(10)MYJW1712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• 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): 07/14/2025

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: 123520A
• Device Lot Number: MYJW1712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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