BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063464 · Received June 20, 2008

    Report

    Report Number
    1036844-2008-00095
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 20, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER FROM THE MEDICAL INTENSIVE CARE UNIT ON A SUBCLAVIAN INSERTION. UPON REMOVAL OF THE .025 SPRING WIRE GUIDE (SWG), IT BECAME SEPARATED INSIDE OF THE PT. HOWEVER, IT WAS REPORTED THE ENTIRE SWG WAS REMOVED. A SECOND PROCEDURE WAS NOT NECESSARY. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention