MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Catalog Number	1758SI16
Medical Device Problem Codes	Material Invagination (1336); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on the (b)(6) 2025, attempted retention of the foley catheter and on the (b)(6) 2025, when trying to remove, there was a sense of discomfort, and it could not be removed.Ultimately, we requested the urologist to remove it, and it was successfully removed.According to the urologist, it may have caught on the fold near the cuff.Please investigate whether there was any defect in the product.If there are no product abnormalities, there was a possibility of cafrol.
Additional Manufacturer Narrative
Initial reporter name: (b)(6).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
Initial reporter name: (b)(6) hospital.Correction- f, h.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 on the (b)(6) 2025, attempted retention of the foley catheter and on the (b)(6) 2025, when trying to remove, there was a sense of discomfort, and it could not be removed.Ultimately, we requested the urologist to remove it, and it was successfully removed.According to the urologist, it may have caught on the fold near the cuff.Please investigate whether there was any defect in the product.If there are no product abnormalities, there was a possibility of cafrol.

• 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, GA 30014 ; +1(770)784-6100
• MDR Report Key: 23857706
• Report Number: 1018233-2025-11383
• Device Sequence Number: 21426247
• Product Code: EZL
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• 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,Followup,Followup
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGJV5463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2026
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 07/20/2026; 08/10/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/06/2026; 08/05/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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; Required Intervention
• Patient Sex: Unknown