BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8 IN (2

    MDR report key: 1196350 · Received October 10, 2008

    Report

    Report Number
    1036844-2008-00200
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT UPON REMOVAL, THE SPRING WIRE GUIDE (SWG) SEPARATED INSIDE OF THE PT. THE PHYSICIAN PERFORMED A CUT DOWN TO REMOVE THE SWG. THE SWG WAS REMOVED AND THERE WERE NO FURTHER COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8 IN (2 ARROWGUARD CATHETER PRODUCTS DQO ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention