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 Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

Foley in place for seven days.It was found to be leaking at the seam where the green drainage port connects to the bag.Foley catheter was exchanged.

• 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.; 428 powerhouse rd.; moncks corner SC 29461
• MDR Report Key: 10939836
• MDR Text Key: 219330831
• Report Number: 10939836
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGET0216
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21900 DA