BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY SYMBIQ SET

    MDR report key: 2191900 · Received July 27, 2011

    Report

    Report Number
    2191900
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 27, 2011
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTING TO FLUSH THE TUBING WHEN THE FILTER WITH IN THE TUBING, THE FILTER BROKE AND CHEMO LEAKED OUT ONTO THE PATIENTS BEDDING. THERE WAS THE POTENTIAL FOR EXPOSURE TO PATIENT AND THE NURSE; NEITHER CAME INTO CONTACT WITH THE CHEMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY SYMBIQ SET INTRAVASCULAR TUBING FPA HOSPIRA * 03034 5H

    Patients

    Seq Age Sex Outcome Treatment
    1 * CHEMOTHERAPY