Events

Notificaciones De Seguridad De Campo acerca de MiniCap-Disconnect Cap

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 BAXTER HEALTHCARE.

¿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
    2015-06-02
  • Fecha de publicación del evento
    2015-11-02
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2015/02/11/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-minicap-disconnect-cap-model-spc4466-kapica-za-transfer-set-za-peritonealnu-dijalizu/
  • 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
    Due to the fact that the manufacturer has recently received complaints from users stating that the sponge soaked with a povidone-iodine solution is completely separated from the cap, partially protruding from the cap, or even missing. using a minicap product that is damaged or missing a sponge with povidone-iodine may compromise the ability of the product to provide a sterile protective barrier at the end of the inter-catheter when the patient undergoes dialysis. this can cause an increased risk of peritonitis. then, using minicap products where the sponge partially protrudes from the cap may encourage improper aseptic technique, such as accidentally touching the sponge to move inside the cap. this can cause an increased risk of peritonitis. the manufacturer notes that there have been no reported adverse events regarding this product series.

Device

MiniCap-Disconnect Cap
  • Modelo / Serial
    SPC4466 - 14B23H15; BEPC4466 - 13J23H15
  • Manufacturer
    BAXTER HEALTHCARE

Manufacturer

BAXTER HEALTHCARE