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

Catalog Number 119216M

Device Problems Material Separation (1562); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

Bedside rn identified that when she went to "tip back" the foley catheter (it has a built in urimeter), the tubing of the foley catheter separated from the urimeter.Due to this disconnection, she notified cca and cns and verified that the foley catheter system had to be changed out.The patient is on vv ecmo for covid, so is on continuous anticoagulation, so this does carry additional bleeding risk to the pt to have to change out the system.Foley exchange done.Break in system now places patient at risk of caution due to product defect and as previously noted, was placed at increased bleeding risk due to exchange that had to be done because of this product defect.

• 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: 11991113
• MDR Text Key: 255977217
• Report Number: 11991113
• 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: 05/25/2021

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: Lay User/Patient
• Device Catalogue Number: 119216M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 87