BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 5.5 FR X 13 CM

    MDR report key: 1031115 · Received April 18, 2008

    Report

    Report Number
    1036844-2008-00063
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 10, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER, DURING THE INSERTION, DIFFICULTY EXPERIENCED WHILE INTRODUCING THE GUIDEWIRE. THE PHYSICIAN ALSO EXPERIENCED DIFFICULTY WITH REMOVAL OF THE GUIDEWIRE; IT WAS IMPOSSIBLE TO FULLY REMOVE. AS A RESULT, A SCANNER AND X-RAY CONTROL WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 5.5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF6056680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK