MalfunctionOEI
MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER
Received Mar 24, 2015 · Event occurred Mar 22, 2015
Report MW5041741 · MDR key 4645587
Device
Generic name
Ventriclear Ii Ventricular Drainage Catheter
Manufacturer
Medtronic Neurological TechnologiesModel number
UNKNOWNCatalog number
UNK
Lot number
UNKNOWN
Product problems
- Break
- Device Operates Differently Than Expected
Patient
57 YR
- Hematoma
Narrative
Description of Event or Problem
A (B)(6) MALE INVOLVED IN (B)(6) WAS ADMITTED WITH ACUTE SUBDURAL HEMATOMA. PLACEMENT OF IN-DWELLING CATHETER AND EXTERNAL DRAINAGE SYSTEM PLACED ON (B)(6) 2015. WHILE RN WAS DOING THE INITIAL BAG CHANGE FOR THE EVD, THE BAG WAS NOT ABLE TO BE UNSCREWED FROM THE DRAINAGE SYSTEM. RN ASKED MD TO ATTEMPT DRAINAGE BAG DISCONNECTION. WHEN MD TRIED TO DISCONNECT THE BAG, THE CONNECTION PIECE CAME APART. THE DRAINAGE SYSTEM WAS CHANGED BY MD. UNKNOWN POTENTIAL PATIENT HARM. DATES OF USE: (B)(6) 2015.