Events

Alerta De Seguridad para Percuflex Urinary Diversion Stent 6Fr and 7Fr

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Boston Scientific.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-12-09
  • Fecha de publicación del evento
    2016-12-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161209b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: boston scientific percuflex urinary diversion stent 6fr and 7fr medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its percuflex urinary diversion stent 6fr [material number (upn) m0061603250; batch numbers: 19347611, 19347612, 19347613] and 7fr [material number (upn) m0061603300; batch numbers: 19664322, 19698112, 19740986]. the manufacturer is implementing the medical device removal on certain lots of percuflex urinary diversion stent kits in japan only. during the manufacturing process, a swap in the 6fr connectors and 7fr connectors led to the wrong size connectors being included with the stents (i.E. 6fr connectors were packaged with 7fr stents, and 7fr connectors were packaged with 6fr stents). this may result in inability to connect a 7fr stent to the 6fr connector, or an insecure connection between a 6fr stent and a 7fr connector. according to the manufacturer, the most likely adverse effect of these occurrences is a minimal delay in procedure. the customers are advised to discontinue use of and segregate the affected product immediately. product recall is on-going. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 december 2016.

Device

Percuflex Urinary Diversion Stent 6Fr and 7Fr
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Percuflex Urinary Diversion Stent 6Fr and 7Fr
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH