MAUDE Adverse Event Report: B BRAUN 20 GA CLOSED SOFT TIP CATHETER; EPIDURAL CATHETER

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Other  

Event Description

Operating room reported problem with epidural tray; trays with same lot number sequestered by pharmacy until further investigation narrowed down the problem; asked today if company notified - contacted b.Braun with tray lot number (b)(6) 2014 at 11:00, but catheter lot with problem unknown; contact information for anesthesia given to b.Braun representative for more information.

• Brand Name: 20 GA CLOSED SOFT TIP CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 4189820
• MDR Text Key: 5158621
• Report Number: MW5038670
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1