MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. EPIDURAL CATHETER

Model Number 530071

Device Problem Flushing Problem (1252)

Patient Problem No Information (3190)

Event Date 07/24/2015

Event Type  Injury  

Event Description

While using a combined spinal and epidural kit for a patient's controlled epidural anesthetic, the epidural catheter was faulty and would not flush appropriately.The catheter was removed from the patient and still would not flush.No kinks or obstructions noted.Manufacturer: please note that we do not send products to the manufacturer, but you may arrange for pick-up by calling my number below.

• Brand Name: EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B.BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018 3524
• MDR Report Key: 5137876
• MDR Text Key: 28042160
• Report Number: MW5056897
• 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: Risk Manager
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: 530071
• Device Lot Number: 61422407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention