Notificaciones De Seguridad De Campo acerca de ARROW® Kits with BD Eclipse ™ Needles

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Arrow International.

¿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
    2017-04-10
  • País del evento
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    According to the contents of a letter from bd (copy attached), becton-dickinson (bd) has received reports on the removal of the safety cap and injuries from needle punching with a bd eclipse ™ needle. according to customer reports, in some cases, pushing the safety cover over the needle will cause it to fall off, resulting in needle exposure, which can increase the risk of injury from the needle stick. some customer reports state that a "click" is heard before the safety cap is locked (before it is activated), followed by a second "click" when the safety cap is locked over the needle. this can increase the risk of needle stick injuries if the user assumes that the safety cap is locked after the initial "click".

Manufacturer