BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 2-LUMEN 5 FR X 13 CM

    MDR report key: 1171347 · Received September 22, 2008

    Report

    Report Number
    1036844-2008-00178
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ARROW INTL, INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THIS EVENT INVOLVED A MALE PEDIATRIC PT VIA FEMORAL INSERTION. QUINIOTERAPIC MEDICATION WAS TO BE "MANAGED" BY THE PROXIMAL LUMEN; HOWEVER, THE INFUSION WAS FOR THE DISTAL LUMEN, OR VICE IT TURNS. ALSO REPORTED THE SPRING WIRE GUIDE BROKE, AND THE PROCEDURE WAS NOT STOPPED. A SMALL SEGMENT "NOT TO STAY IN THE VEIN." FURTHER DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL, INC. RF7125491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK