BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR, 100CC BURETTE W/ACORN FILTER

    MDR report key: 739872 · Received July 20, 2006

    Report

    Report Number
    2648988-2006-00026
    Event Type
    Malfunction
    Date Received
    July 20, 2006
    Report Date
    July 20, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INTIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    TWO POSSIBLE LOT NUMBERS (1061013; 1061197) HAVE BEEN IDENTIFIED. SECOND AND THIRD REPORTED INCIDENTS OF THE 2ND NEEDLELESS PORT LABELED AS CSF ACCESS LEAKING. THE THIRD INCIDENT OCCURRED LESS THAN 24 HOURS AFTER EVD WAS STARTED AND THE HOSPITAL CONFIRMED THERE WAS NO INTERVENTION TO THE PORT. THE USER FACILITY IS CONCERNED WITH THE POSSIBILITY FOR INFECTION, AND ARE REQUESTING THE PREVIOUS VERSION (SP0187), FOR USE UNTIL THE INVESTIGATION INTO THESE OCCURRENCES ARE COMPLETED. THE SP0187 CONTAINS THE NEEDLE ACCESS PORTS. UPMC ADVISED THEY WILL BE FILING MEDWATCH REPORTS TO THE FDA, TO DATE, WE HAVE NOT RECEIVED COPIES OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONITOR, 100CC BURETTE W/ACORN FILTER EVD FPA INTEGRA NEUROSCIENCES PR * 1061197/1061013

    Patients

    Seq Age Sex Outcome Treatment
    1