BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE BLU DUO CATHETER, 1304-CP2S-7-25-MC-BD

    MDR report key: 3940169 · Received March 21, 2014

    Report

    Report Number
    2030404-2014-00030
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168323 SAFIRE BLU DUO CATHETER, 1304-CP2S-7-25-MC-BD OAD ST. JUDE MEDICAL, INC. (AF-IRVINE) A088107 4270786

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AGILIS NXT INTRODUCER (308410/LOT UNKNOWN)| BIOSENSE WEBSTER LASSO CATHETER (MODEL/LOT UNKNOWN| BIOSENSE/SIEMENS ICE CATHETER (MODEL/LOT UNKNOWN)| BRK TRANSSEPTAL NEEDLE (407200/LOT UNKNOWN)| BRK TRANSSEPTAL NEEDLE (407206/LOT UNKNOWN)| ENSITE NAVX SYSTEM| LIVEWIRE DUO DECA EP CATHETER (401932/LOT UNKNOWN)| SL1 INTRODUCER (MODEL/LOT UNKNOWN)