BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWGARD BLUE PLUS QUAD-LUMEN CVC

    MDR report key: 2577210 · Received May 1, 2012

    Report

    Report Number
    2577210
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    April 19, 2012
    Report Date
    May 1, 2012
    Manufacturer
    TELEFLEX INC,
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PLACING CENTRAL LINE. AFTER PLACING THE LINE IT WAS NOTICED THAT ONE OF THE PORTS WAS LEAKING. IT WAS THE WHITE PROXIMAL PORT BELOW THE HUB. THE PORT WAS CLAMPED AND LABELED NOT TO USE AND WAS SAVED ONCE THE DEVICE WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWGARD BLUE PLUS QUAD-LUMEN CVC CATHETER, INTRAVASCULAR FOZ TELEFLEX INC, AK-45854-SK RF1117405 120711 1154

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR