Events

Alerta De Seguridad O Notificaciones De Seguridad para TransRadial artery access kit

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/083
  • Número del evento
    CON354193
  • Fecha
    2013-12-13
  • Fecha de publicación del evento
    2013-12-13
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON354193?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of delay to patient treatment. arrow international are recalling certain models and lot numbers of their transradial artery access kits because the introducer needles packaged within the kits can be partially or fully occluded. arrow international issued a field safety notice (fsn) dated 9 october 2013. the fsn lists the part and lot numbers that are affected. the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Acción
    Identify and quarantine affected kits pending return to Teleflex Medical. Ensure that all users are aware of the advice given in the Arrow International FSN for identifying and returning affected stock. Fill in the acknowledgement form in the FSN and return it to Teleflex Medical.

Device

TransRadial artery access kit
  • Modelo / Serial
  • Descripción del producto
    TransRadial artery access kit. (a division of Teleflex Medical). Specific part numbers and lot numbers.
  • Manufacturer
    Arrow International

Manufacturer

Arrow International