BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER

    MDR report key: 4645587 · Received March 24, 2015

    Report

    Report Number
    MW5041741
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    March 22, 2015
    Report Date
    March 24, 2015
    Manufacturer
    MEDTRONIC NEUROLOGICAL TECHNOLOGIES
    Product Code
    OEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197539 MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER OEI MEDTRONIC NEUROLOGICAL TECHNOLOGIES UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR