MAUDE Adverse Event Report: C.R. BARD, INC. BARDEX 3-WAY URETHRAL CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number 0167SI24

Device Problems Material Integrity Problem (2978); No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

Catheter stopped draining urine - nurse went to deflate balloon to change the catheter at which time no liquid was removed.The catheter was easily removed - nurse then noted the port to attach syringe was damaged.

• Brand Name: BARDEX 3-WAY URETHRAL CATHETER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 17005330
• MDR Text Key: 316103707
• Report Number: MW5117879
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0167SI24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male