BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASEAL

    MDR report key: 2240724 · Received August 26, 2011

    Report

    Report Number
    2240724
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    CARMEL PHARMA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT TO RECEIVE PAXITAXOL INFUSION. PHASEAL WAS ATTACHED TO MAINLINE TUBING WITHOUT DIFFICULTY. AFTER INFUSION WAS STARTED, THE PATIENT BEGAN NOTICING SHE WAS "GETTING WET." STAFF DISCOVERED A LEAK IN THE PHASEAL AT THE Y-SITE. PATIENT'S CLOTHING WAS SATURATED AND THE SKIN WAS EXPOSED TO THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHASEAL INTRAVASCULAR TUBING FPA CARMEL PHARMA * 446307

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES