Events

Notificaciones De Seguridad De Campo acerca de Fem-Flex II Femoral Arterial Cannula

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por EDWARDS LIFESCIENCES.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2014-05-06
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/05/06/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-fem-flex-ii-femoral-arterial-cannula/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has received five reports in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16, 18 and 20 french. some of the reporeted vevents invovled separation of the tip of the dilator required through an interventional radiologic procedure. it was first reported in december of 2016 for lots manufacturet as early as march, 2011. the investigation determined that the dilator made specifically for the 16, 18 and 20 french sizes presented a hazard during use. based on the potential impact to patients, edwards is recalling the 16, 16 and 20 french sizes of the fem-flex ii aretrial cannulae that have not expired.

Device

Fem-Flex II Femoral Arterial Cannula
  • Modelo / Serial
    16 - DFEMII016AS, DIIFEMII016A, FEMII016A, FEMII016AS; 18 - DFEMII018AS, DIIFEMII018A, FEMII018A, FEMII018AS; 20 - DFEMII020AS, DIIFEMII020A, FEMII020A, FEMII020AS
  • Manufacturer
    EDWARDS LIFESCIENCES

Manufacturer

EDWARDS LIFESCIENCES