MAUDE Adverse Event Report: B BRAUN B BRAUN EPIDURAL CATHETER

Device Problem Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 06/04/2015

Event Type  Injury  

Event Description

Crna attempted to place epidural catheter.However, she was unable to feed epidural catheter through tuohy needle past 9 cm.Catheter was withdrawn.Crna noted 2 cm of catheter to be absent from end of catheter.Another crna reported a separate, but recent issue in which she was unable to feed catheter.Another kit was obtained and another crna was able to insert epidural without issue.Lot number unknown as packaging not saved.Lots currently in ob (b)(4) (only one left).

• Brand Name: B BRAUN EPIDURAL CATHETER
• Type of Device: B BRAUN
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 4888256
• MDR Text Key: 6069416
• Report Number: MW5043449
• 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: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• 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
• Patient Age: 28 YR
• Patient Weight: 64