BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 16 CM

    MDR report key: 740797 · Received July 21, 2006

    Report

    Report Number
    1036844-2006-00052
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    March 1, 2006
    Report Date
    July 21, 2006
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT THAT DURING A CATHETER EXCHANGE THE CATHETER INADVERTENTLY SLIPPED AND LODGED INTO THE PATIENT'S FEMORAL VEIN. EMERGENT RETRIEVAL OF THE CATHETER WAS REQUIRED AND WAS PERFORMED IN INTERVETIONAL RADIOLOGY. IT WAS NOTED THIS WAS A USER ERROR. THERE WERE NO ASSOCIATED PATIENT COMPLICATIONS REPORTED. THE EVENT OCCURRED IN 2006. ARROW INTERNATIONAL, INC. WAS NOT NOTIFIED UNTIL 4 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention