MAUDE Adverse Event Report: MEDTRONIC NEUROLOGICAL TECHNOLOGIES MEDTRONIC DUET EVD; VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM

Device Problem Failure to Disconnect (2541)

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

Event Date 05/24/2015

Event Type  malfunction  

Event Description

A (b)(6) female admitted with stroke symptoms and ivh on (b)(6) 2015.Taken to operating room on (b)(6) 2015 for ventricular drain insertion with csf fluid collection system attached.On (b)(6) 2015, rn was doing a routine initial evd bag change.Difficulty was encountered when rn attempted to disconnect the bag from the drip chamber at the luer lock site.Luer lock became disconnected at the top of the device instead of at the bottom.Luer lock was reattached to the drip chamber and the fluid in the bag was removed from the bottom access port with a syringe.Dates of use: (b)(6) 2015.Diagnosis or reason for use: stroke.

• Brand Name: MEDTRONIC DUET EVD
• Type of Device: VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM
• Manufacturer (Section D): MEDTRONIC NEUROLOGICAL TECHNOLOGIES; 123 cemona dr.; goleto CA 93117 550
• MDR Report Key: 4905740
• MDR Text Key: 20033825
• Report Number: MW5043912
• Device Sequence Number: 1
• Product Code: PCB
• 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: 06/22/2015

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 04/20/1
• Patient Weight: 94