BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ICP MONITORING CATHETER W/INTEGRATED LIC

    MDR report key: 1942094 · Received November 11, 2010

    Report

    Report Number
    2023988-2010-00040
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 11, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A CAMINO ICP MONITORING CATHETER (1104L) WAS INVOLVED IN AN INCIDENT AND WAS DESCRIBED AS FOLLOWS: THE PT HAD THE CATHETER TAPED SECURELY TO AN ARM BOARD, (THE PROTOCOL USED SINCE 2001 TO SECURE THE UNIT IN PLACE) WHEN THE CATHETER SNAPPED OR SHEARED WHEN THE PT WAS TURNED. THE NURSING STAFF INDICATED THAT THE CATHETER WAS NOT ACCIDENTALLY BUMPED. THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS INCIDENT, BUT REQUIRED ADDITIONAL SURGERY WITH WHICH TO INSERT ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO ICP MONITORING CATHETER W/INTEGRATED LIC NA GWM INTEGRA NEUROSCIENCES SD POSS 305000192401

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR