MEDTRONIC DUET EVD UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for MEDTRONIC DUET EVD UNK manufactured by Medtronic Neurological Technologies.

Event Text Entries

[20033825] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5043912
MDR Report Key	4905740
Date Received	2015-07-06
Date of Report	2015-06-22
Date of Event	2015-05-24
Date Added to Maude	2015-07-13
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	MEDTRONIC DUET EVD
Generic Name	VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM
Product Code	PCB
Date Received	2015-07-06
Model Number	UNK
Catalog Number	UNK
Lot Number	UNK
ID Number	UNK
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	MEDTRONIC NEUROLOGICAL TECHNOLOGIES
Manufacturer Address	123 CEMONA DR. GOLETO CA 93117550 US 93117 550

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-07-06