MAUDE Adverse Event Report: C.R. BARD, INC. BARDEX LUBRI-SIL ALL-SILICONE 18 FR TEMP SENSING FOLEY; CATHETER, RETENTION TYPE, BALLOON

Model Number 119218M

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

Catheter leaking where the bag connects to the green drainage port.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE 18 FR TEMP SENSING FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 19191593
• MDR Text Key: 341155176
• Report Number: 19191593
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2023

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 Model Number: 119218M
• Device Catalogue Number: 119218M
• Device Lot Number: NGGN1010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female