MAUDE Adverse Event Report: B. BRAUN PERIFIX EPIDURAL CATHETER

Model Number 555030

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/19/2015

Event Type  Injury  

Event Description

Epidural catheter sheared off (approx 12 cm) inside of pt during epidural placement for labor.

• Brand Name: PERIFIX EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN; bethlehem PA 18018
• MDR Report Key: 4939052
• MDR Text Key: 6257782
• Report Number: MW5044708
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 555030
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Weight: 104