MAUDE Adverse Event Report: MEDTRONIC DUET EVD

Model Number DUET

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/24/2014

Event Type  malfunction  

Event Description

Medtronic duet evd came apart at the distal stopcock (side of the stopcock that leads to the drain).

• Brand Name: DUET EVD
• Type of Device: DUET
• Manufacturer (Section D): MEDTRONIC; CA
• MDR Report Key: 3713161
• MDR Text Key: 4265026
• Report Number: MW5035344
• Device Sequence Number: 1
• Product Code: JXG
• 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: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUET
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LUMBAR DRAIN; IV PUMPS; PNEUMOBOOTS
• Patient Age: 19 YR
• Patient Weight: 105