BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICOMP PORT CT IMPLANT (SILICONE) 9.6 FR

    MDR report key: 2428361 · Received January 19, 2012

    Report

    Report Number
    MW5023936
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 19, 2012
    Manufacturer
    MEDICOMP
    Product Code
    GBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, (B)(6) YEAR OLD FEMALE RECEIVING CHEMOTHERAPY VIA MEDIPORT. STAFF ATTEMPTED TO FLUSH MEDIPORT BEFORE CHEMO ADMINISTRATION. PT EXPERIENCED PAIN AT SITE AND FLUID SEEN AROUND HUB AT INSERTION SITE. DYE STUDY REVEALED MEDIPORT HAD SEPARATED/RUPTURED INTERNALLY. VASCULAR SURGEON ABLE TO REMOVE TIP OF CATHETER FROM PT'S PULMONARY ARTERY WAS VASCULAR CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICOMP PORT CT IMPLANT (SILICONE) 9.6 FR MEDIPORT 9.6F MS DIGNITY CT PORT GBW MEDICOMP MBFT860

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention