MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER

Catalog Number	119314M
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the foley with a temperature probe indicated temperature 38.8 degrees c at 0800 on 8/5 and continued to rise reaching up to 42.2 degrees c at 1245.Esophageal temperature probe placed at 1250 to compare readings, which read 33.7 degrees c.Esophageal temperature probe was confirmed for placement via chest x-ray.This patient was treated with ice packs and scheduled tylenol and lorazepam 1 gm iv for presumption of presence of seizures with the high temperature.They were also drawn blood cultures on 8/4 due to temperatures above 38.3 during that day.
Event or Problem Description
It was reported that the foley with a temperature probe indicated temperature 38.8 degrees c at 0800 on (b)(6) and continued to rise reaching up to 42.2 degrees c at 1245.Esophageal temperature probe placed at 1250 to compare readings, which read 33.7 degrees c.Esophageal temperature probe was confirmed for placement via chest x-ray.This patient was treated with ice packs and scheduled tylenol and lorazepam 1 gm iv for presumption of presence of seizures with the high temperature.They were also drawn blood cultures on (b)(6) due to temperatures above 38.3 during that day.Per follow up information received via email on 12nov2025, it was reported that the customer does not have any physical samples, or lot/serial numbers.Customer was unsure of what kind of troubleshooting could be performed on this device.Additionally, once the catheter was placed it was not our practice to save the packaging.Customer do have patient information, but they were unsure what was hospital policy on providing the details to individuals outside of organization for this type of situation.The report that customer have about the patient was almost word-for-word the same information that was given already.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.Instructions for use were reviewed for this investigation.The reported event is addressed within the labeling as it states, visually inspect the product for any imperfections or surface deterioration prior to use.A dhr could not be performed since no lot number was provided.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® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING 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 ; 7707846100
• MDR Report Key: 23488461
• Report Number: 1018233-2025-09999
• Device Sequence Number: 10499250
• Product Code: MJC
• UDI-Device Identifier: 00801741039904
• UDI-Public: (01)00801741039904
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• 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): 12/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 119314M
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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