MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Model Number 313003

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Event Description

The drip chamber of the tubing for the continuous bladder irrigation was found to have a slow leak - the tubing was changed to new device without issue.

• Brand Name: IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7633439
• MDR Text Key: 112184465
• Report Number: 7633439
• Device Sequence Number: 1
• Product Code: LJH
• 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: 06/20/2018

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: No Information
• Device Model Number: 313003
• Device Catalogue Number: 313003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Date Report to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA