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 Problems Fluid/Blood Leak (1250); Defective Device (2588)

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

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Urinary catheter balloon defect causing urinary leakage and changing of invasive device.

• 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: 11027051
• MDR Text Key: 222068308
• Report Number: 11027051
• 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: 12/10/2020

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: Health Professional
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: 119216M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1