MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 119216M

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2020

Event Type  malfunction  

Event Description

Inaccurate temperature that we were treating.Temp 40c.When adding 2nd temp source for esophageal cooling the temperature was lower than urinary catheter temperature.We changed device and pt normothermic.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10046466
• MDR Text Key: 190622050
• Report Number: 10046466
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2020

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
• Device Operator: No Information
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGDX4591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2020
• Date Report to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1