Events

Notificaciones De Seguridad De Campo acerca de BD Eclipse™ Injection Needle and others

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 BD.

¿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
  • País del evento
    Slovenia
  • 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
    Bd has received reports of safety cover/shield disengagement, which has the potential to lead to a needlestick injury (nsi) when using the bd eclipse™ injection needle and bd preset™ eclipse™ arterial blood collection syringes. based on the customer reports, in some cases when the safety cover/shield is pushed over the needle it disengages, resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible “click” sound before the safety cover/shield is locked (activated) followed by a second “click” sound when the safety cover/shield is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover/shield is locked after the initial “click”. .

Device

BD Eclipse™ Injection Needle and others
  • Modelo / Serial
  • Manufacturer
    BD

Manufacturer

BD