MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bardex® Lubricath® Temperature Sensing Foley Catheter

Catalog Number	119416M
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that after placing temperature sensing foley catheter the rn discovered that the temperature probe appeared damaged and/or crushed.The foley catheter was removed, and a new foley catheter was placed that had a functional temperature probe.The patient experienced discomfort due to the removal and replacement of the foley catheter.There is no known harm to the patient at this time.Per customer via email on (b)(6) 2026 the lot number is nglq0447 and serial number (b)(6).Upon discovery of the temp probe being damaged and nonfunctional, the foley catheter had to be removed and replaced.This caused a delay in care and discomfort to the patient due to the removal and replacement of the catheter.
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® Lubricath® Temperature Sensing 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: 25826332
• Report Number: 1018233-2026-04664
• Device Sequence Number: 15887848
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148(17)280531(10)NGLQ0447
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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,Followup
• Report Date (Section B): 09/15/2026

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: 119416M
• Device Lot Number: NGLQ0447
• Was Device Available for Evaluation?: No
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 09/10/2026; 09/15/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/11/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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 Age: 61 YR
• Patient Sex: Unknown