Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Cordis Corporation.

¿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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 086 11 17 001
  • Fecha de inicio del evento
    2018-03-07
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12251
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Based on one complaint and the subsequent investigation, cordis has determined that 85 distributed lots of s.M.A.R.T.® flex vascular stent system have a potential for cracked luer hubs, due to a manufacturing error. the luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter.

Device

Cordis S.M.A.R.T.® Flex Vascular Stent System.
  • Modelo / Serial
    85 lot numbers of 48 catalog numbers. Reference Table 1. The lot number range is from 40932 through 41637, but not all lots in the range are affected. .................................. NCMDR Update Code: GTIN: Catalog No. 20705032066607: SF06100SV 20705032066805: SF07200SV 20705032066591: SF08060SV 20705032066768: SF08100MV 20705032067192: SF08100SV 20705032066645: SF10040SV Multiple Lot numbers of the affected device are provided in the attached FSN
  • Descripción del producto
    Flex Vascular Stent System
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA