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

Catalog Number 119416M

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported that once inserted the foley catheter failed to drain the bladder.Bladder scan confirmed urine present and they removed the catheter and found the product to be defective.They were unable to flush water through the lumen of the catheter.Per additional information received via email on 08apr2024, it was reported that the customer had another foley catheter that did not work in cardiovascular operating room (cvor) and needed to be replaced intraoperatively that day.In each event, the temperature sensing foley catheter was inserted into the bladder successfully.Neither of these foley catheters produced urine return.Bladder scans post insertion confirmed urine present in the bladder.The foleys were removed in each event.They planned to look at the lot number of the affected product and pulled all foley kits with same lot number from inventory to be safe.They were very concerned that they might have other affected product throughout the hospital that was placing their patient at risk.This was now a patient safety issue and would like some kind of follow up from bd along with credit for all the kits that they were removing from inventory.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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
• Type of Device: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19104510
• MDR Text Key: 340690953
• Report Number: 1018233-2024-02060
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741046148
• UDI-Public: (01)00801741046148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

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: Health Professional
• Device Catalogue Number: 119416M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other