MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® TEMPERATURE-SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER

Model Number	119416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be " tortuous anatomy".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Using proper aseptic methods, remove catheter from package.Prepare patient per hospital/nursing recommended procedure.Proceed with catheterization using standard techniques.Inflate the 5cc balloon with a maximum of 10cc sterile water by inserting tip of water-filled luer-tip syringe gently into valve.Do not use a needle.Connect catheter to collection container.Connect temperature plug to appropriate patient monitor.To deflate the 5cc balloon, gently reinsert the luer tip syringe into the valve and aspirate.When temperature monitoring is no longer required, sever cord at valve arm with scissors and cover valve arm containing severed cord with adhesive tape.".
Event or Problem Description
It was reported that the customer mentioned about symptomatic urinary tract infection and accidental removal when they were asked of the complications while using the temperature sensing foley catheter.Medical intervention was unknown.

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15437556
• Report Number: 1018233-2022-07200
• Device Sequence Number: 6005624
• Product Code: EZC
• UDI-Device Identifier: 00801741076947
• UDI-Public: (01)00801741076947
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 119416
• Device Catalogue Number: 119416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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