BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN II NC HV WITH GUIDEWAIRE INTRODUCER

    MDR report key: 2748545 · Received September 13, 2012

    Report

    Report Number
    3005395947-2012-00001
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    July 23, 2012
    Report Date
    September 12, 2012
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    PMA / PMN Number
    K101113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A GUARDIAN II NC POUCH WAS DISCOVERED BY A CUSTOMER TO BE UNSEALED. THE DEVICE WAS NOT USED ON THE PATIENT AND NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN II NC HV WITH GUIDEWAIRE INTRODUCER HEMOSTASIS VALVE PRODUCT CODE: DTL DTL VASCULAR SOLUTIONS ZERUSA LIMITED FH102 27686

    Patients

    Seq Age Sex Outcome Treatment
    1