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

Catalog Number	175816
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wanted to let you know that they had a foley catheter with a hole in that.It was placed in the patient, inflated, 10ml syringe disconnected, then while cleaning everything up they noticed that had fully come out.I tested that after and found a hole underneath the balloon in the tubing.It was thrown away since that was in the patient.Per customer follow up received via email on (b)(6) 2026 stated that there was no patient impact and they had the device in their office.
Additional Manufacturer Narrative
The investigation did not reveal any additional findings as the sample was not available to allow for further evaluation.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.Udi format updated with available product information per gudid.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® 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: 50124268
• Report Number: 1018233-2026-05114
• Device Sequence Number: 20252693
• Product Code: EZL
• UDI-Device Identifier: 00801741074141
• UDI-Public: (01)00801741074141(17)280831(10)NGLS1249
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 175816
• Device Lot Number: NGLS1249
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2026
• 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