Events

Notificaciones De Seguridad De Campo acerca de Certofix Duo Certofix Trio Drucafix

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 B. Braun Melsungen AG.

¿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
  • Fecha
    2016-12-21
  • 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
    During production we observed in an isolated case that a female luer connector was not fully connected to the extension line of the certofix catheter. upon further intensive testing, we could identify the root cause of the defect and are able to limit a possible occurrence of the failure to the below listed product/batch combinations. the failure appears only at white and yellow luer connectors and occurs at a very low rate. the failure can be identified by the user. a disconnection of the luer connector from the extension line has the potential to cause air embolism and other serious patient harm. we therefore advise to discontinue usage of the affected product/batch combinations or - in case of an undersupply situation - identify potentially affected products according to the below described procedure. .

Device

Certofix Duo Certofix Trio Drucafix
  • Modelo / Serial
    Article Number Article Name Batch 4161211 CERTOFIX DUO V 720 16M15A8551 4161319 CERTOFIX DUO V 730 16M21A8551 4163214 CERTOFIX TRIO V720 16M17A8551 16M16A8551 4163306 CERTOFIX TRIO S 730 16M18A8551 4164158 CERTOFIX DUO S 715 16M24A8551 4167385 CERTOFIX DUO S 720 16M18A8551 4167408 CERTOFIX TRIO S 720 16M28A8551 4162200E CERTOFIX DUO 720 16M21A8551 16M22A8551 4163206E CERTOFIX TRIO 720 16M11A8551 4167408S CERTOFIX SAFETY TRIO S 720 16M08A8551 4166906 CERTOFIX DUO PAED S 408 16M24A8551 4166922 CERTOFIX DUO PAED S 413 16M18A8551 227599 DRUCAFIX WITH SPLITTOCAN 16L20A8701 16L07A8701 4162153 CERTOFIX TRIO V 715 16M22A8551 16M24A8551 16M25A8551
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG