Events

Alerta De Seguridad para BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits

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

¿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
    2012-07-05
  • Fecha de publicación del evento
    2012-07-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120705.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: bd prepstain™ diti 1.2 and diti 1.2 upgrade kits medical device manufacturer, becton, dickinson and company (bd), has issued a medical device safety alert on bd prepstain™ diti 1.2 (catalogue no.: 750-07024-00, sap: 490670) and diti 1.2 upgrade kits (catalogue no.: 750-07377-02, sap: 491074). bd has confirmed through a complaint investigation that bd prepstain instruments with diti cone may leak. the diti is the tip on the bd prepstain to which a pipette tip attaches that dispenses patient samples into the settling chamber. this issue may affect bd prepstain instruments shipped between 16 february 2011 and november 2011. according to the manufacturer, there are no health or safety risks associated with this issue and there have been no injuries reported. the manufacturer has advised all field service representatives to inspect bd prepstain diti 1.2 installation to ensure the parts are secure. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 5 july 2012.

Device

BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits
  • Manufacturer
    Becton

Manufacturer

Becton