MAUDE Adverse Event Report: B BRAUN; EPIDURAL ANESTHESIA TRAY

Catalog Number 332078

Device Problem No Flow (2991)

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

Event Date 10/24/2015

Event Type  malfunction  

Event Description

Braun epidural catheter placed easily, however, after the connector was snapped into place, no fluid could be injected or aspirated through the catheter.Epidural catheter removed and a new braun catheter placed with same outcome.

• Type of Device: EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B BRAUN; bethlehem PA 18018
• MDR Report Key: 5201271
• MDR Text Key: 30466979
• Report Number: MW5057651
• 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: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 332078
• Device Lot Number: 61445383
• 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 Age: 22 YR