MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B. BRAUN; EPIDURAL ANESTHESIA TRAY

Lot Number 0061687977

Device Problem Structural Problem (2506)

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

Event Date 10/04/2019

Event Type  malfunction  

Event Description

"caid" at tip of catheter "spools" apart during insertion.

• Brand Name: B. BRAUN
• Type of Device: EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 9245049
• MDR Text Key: 164295192
• Report Number: MW5090703
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/01/2020
• Device Lot Number: 0061687977
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1