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

Catalog Number	119314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that spontaneous detachment due to leak in the balloon section.
Additional Manufacturer Narrative
Evaluation determined that the product did not meet specifications; this is addressed by capa 12866756.Visual: received 1 all silicone foley catheter with syringe attached to a drainage bag.Verified material number 119314 and manufacturing lot number ngkx5300.Visual inspection noted the catheter balloon had ruptured.Further inspection noted the balloon had no missing pieces.Functional: inflated catheter with 10ml mbs using slip tip syringe.Upon inflation leakage at balloon due to rupture.Per capa 12866756 the potential root cause is: silicone balloon molding pin configuration when removing the balloon from the mold.Inspection method: the inspection method is visual and relies on the operator¿s judgment to identify any leakage in the catheter balloon during the inflation/deflation inspection test at 100 percent final inspection.The labeling is found to be adequate.Dhr review is not required as event has already been investigated per capa 12866756.Corrections: d, f, h.Udi format updated with available product information per gudid.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: Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter
• 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: 50329555
• Report Number: 1018233-2026-05455
• Device Sequence Number: 17580112
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• 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): 09/22/2026

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: 119314
• Device Lot Number: NGKX5300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• 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: 09/22/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• 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