BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO VENTRICULAR BOLT

    MDR report key: 791408 · Received December 5, 2006

    Report

    Report Number
    2023988-2006-00055
    Event Type
    Injury
    Date Received
    December 5, 2006
    Report Date
    December 4, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    GWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PHYSICIAN INSERTED A CAMINO CATHETER INTO A PATIENT, BUT COULD NOT GET THE DEVICE TO ZERO. THE MONITOR DISPLAYED THREE HASH MARKS. ANOTHER CATHETER WAS USED, FROM THE SAME LOT NUMBER AND WOULD NOT ZERO. THE DEVICES ARE BEING RETURNED FOR EVALUATION ALONG WITH UNUSED DEVICES FOR A TOTAL OF SIX DEVICES IN ALL. THIS INCIDENT IS RELATED TO MDR 2023988-2006-00054.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT ICP DISPOSABLE GWM INTEGRA NEUROSCIENCES * W051420

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention