MAUDE Adverse Event Report: C.R. BARD, INC. BARDEX18 FR COUDE CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number 0102SI18

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Hematuria (2558)

Event Date 12/31/2022

Event Type  malfunction  

Event Description

Describe event, problem, or product use error: pt requested to use the restroom.When returning to bed catheter was laying on the bed, no longer in place.Catheter was not pulled by patient.On exam of the catheter, notice the balloon was no longer attach and completely removed from coude catheter.Md notified.Stat us ordered.Hematoma seen on ultrasound.Manual irrigation ordered.Hematuria resolved.Pt to follow up with urology as an outpatient.

• Brand Name: BARDEX18 FR COUDE CATHETER
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 16195535
• MDR Text Key: 307729117
• Report Number: MW5114367
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0102SI18
• Device Catalogue Number: 0102SI18
• Device Lot Number: NGGX1983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1