MAUDE Adverse Event Report: B BRAUN CUSTOM EPIDURAL KIT; EPIDURAL CATHETER

Device Problem Flushing Problem (1252)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

Epidural catheter inserted for labor management.Catheter wouldn't flush.

• Brand Name: CUSTOM EPIDURAL KIT
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 4182046
• MDR Text Key: 5156298
• Report Number: MW5038633
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Patient Age: 35 YR
• Patient Weight: 79