MAUDE Adverse Event Report: B BRAUN B. BRAUN CUSTOM SPINAL AND EPIDURAL ANESTHESIA TRAY

Model Number SESK

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: B. BRAUN CUSTOM SPINAL AND EPIDURAL ANESTHESIA TRAY
• Type of Device: B. BRAUN CUSTOM SPINAL AND EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 4189820
• MDR Text Key: 5158621
• Report Number: MW5038670
• Device Sequence Number: 2
• 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
• Device Expiration Date: 01/01/2016
• Device Model Number: SESK
• Device Catalogue Number: 530024
• Device Lot Number: 61376392
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1