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 Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after being placed in op, it was discovered that the foley catheter had come out in the ward.Similar cases occur frequently.Natural drainage.
Additional Manufacturer Narrative
Evaluation determined the product met specifications and no product nonconformance was identified.Visual: visual evaluation of the returned sample noted one opened (without original packaging), all silicone foley catheter attached to a drainage bag.Verified material number 119314 and manufacturing lot number ngkn0783.Visual inspection noted no obvious observations.Functional: inflated balloon with 10 ml of solution using the in house luer lock syringe and the catheter rested with no leaks noted.Deflated balloon passively with no cuffing or leaks noted.Flushed the drainage lumen with d.I.Water and it exited through the eyelets with no other leaks or defects noted.Flushed the sample port and filled the drainage bag with blue methyl solution and d.I, water and there were no leaks noted.Our team conducted a review of the reported event using all available information to ensure the continued safety and performance of the product.The investigation has been completed and determined that this issue represents a known failure mode, which has been previously assessed in the product risk management file in accordance with applicable regulatory standards and internal procedures.The associated risks continue to be actively monitored as part of our ongoing post market surveillance activities in compliance with regulatory requirements and company procedures.Based on the results of the investigation, no further action is required at this time.Corrections: d, 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: 50456181
• Report Number: 1018233-2026-05573
• Device Sequence Number: 9763047
• 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: NGKN0783
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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