MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Foley Catheter Silicone Coated; Latex Silicone Foley Catheter

Catalog Number	0167V20S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the department reported the balloon ruptured during use.Product model 123420c.The department has been using this product for many years and reports no operational issues.This is the fourth instance of rupture or detachment involving this same product at the same hospital within a short period of time.Please investigate the root cause to prevent damage to the products 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.A potential root cause for this failure mode could be due to short latex dwell time, latex dip speed out too slow causing thin sac.Labeling review not required.No non conformities were identified in any of the dhrs.Therefore, no additional action required at this time.Correction: d.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® Foley Catheter Silicone Coated
• Common Device Name: Latex Silicone 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: 50084498
• Report Number: 1018233-2026-05000
• Device Sequence Number: 16032322
• Product Code: KOD
• UDI-Device Identifier: 00801741019227
• UDI-Public: (01)00801741019227(11)240810(17)290328(10)MYJS4760
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: 0167V20S
• Device Lot Number: MYJS4760
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2024
• 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