MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardia® Foley Catheter Silicone Coated

Catalog Number	123514A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
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 recently, there have been frequent reports of foley catheter balloon ruptures during departmental use, mainly with model 123514c.The department had been using it for years and says there was no problem with their operation.Also please investigate the root cause of the problem to avoid damaging the product¿s reputation within the department.
Event or Problem Description
It was reported that recently, there have been frequent reports of foley catheter balloon ruptures during departmental use, mainly with model 123514c.The department had been using it for years and says there was no problem with their operation.Also please investigate the root cause of the problem to avoid damaging the product¿s reputation within the department.
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 due to thin sac causing by short latex dwell time, latex dip speed out too slow.The labeling is found to be adequate.Lot file review was performed on the lot and does not indicate any reject or rework associated with this issue.No nonconformities or discrepancies were noted on the dhr.Corrections: d, g.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 ; +1(770)784-6100
• MDR Report Key: 25566031
• Report Number: 1018233-2026-04043
• Device Sequence Number: 21351511
• Product Code: EZC
• UDI-Device Identifier: 00801741095085
• UDI-Public: (01)00801741095085(11)240626(17)290228(10)MYJS2337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 123514A
• Device Lot Number: MYJS2337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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