MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Catalog Number	1758SI14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, shortly after starting urinary leakage was seen.No medical intervention was reported.Per follow up information received via ibc on 15jul2025, stated that the actual event for which urinary incontinence happened was unknown and no patient or user was harmed.
Event or Problem Description
It was reported that during surgery, shortly after starting urinary leakage was seen.No medical intervention was reported.Per follow up information received via ibc on (b)(6)2025, stated that the actual event for which urinary incontinence happened was unknown and no patient or user was harmed.
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.
Additional Manufacturer Narrative
Evaluation determined the product did not meet specifications.Capa (b)(4)related issues were identified.Received (b)(4) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), used drainage bag with an inlet tubing, sample port connector, catheter, tes.Visual inspection of the sample shows no visual defects present.The reported failure could not be evaluated because it is unknown how the product interacted with the patient's anatomy; therefore, this investigation is considered inconclusive.Inflated the catheter balloon using in-house luer lock syringe with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.Deflated balloon passively with no cuffing or leaks noted.Attempted to flush the drainage lumen with blue methyl solution and d.I.Water and it immediately leaked out of a 0.038" pinhole found on the drainage funnel where the silicon mold meets.Further testing noted flushed the sample port and filled the drainage bag with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks observed.The labeling is 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.Corrections made to tab(s) d and 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® Lubri-Sil® I.C. All-Silicone Foley Catheter
• Common Device Name: 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 30014 ; +1(770)784-6100
• MDR Report Key: 50578065
• Report Number: 1018233-2026-05684
• Device Sequence Number: 18569008
• Product Code: MJC
• UDI-Device Identifier: 00801741025211
• UDI-Public: (01)00801741025211(11)240926(17)290925(10)NGJT2045
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• 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): 09/09/2026

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: 1758SI14
• Device Lot Number: NGJT2045
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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