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

Model Number 332220

Device Problem Disconnection (1171)

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

Event Date 03/02/2019

Event Type  malfunction  

Event Description

Patient's epidural disconnected from the tubing resulting in risk contamination.The epidural was required to be removed and the epidural medication had to be discontinued.

• Brand Name: CONT. EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL ANESTHESIA CE KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 8413997
• MDR Text Key: 138690850
• Report Number: MW5084825
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 332220
• Device Catalogue Number: GTIN 04046964178313
• Device Lot Number: 0061628279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 85 YR