Events

Notificaciones De Seguridad De Campo acerca de Mueller-Hinton broth

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 Remel Inc., part of Thermo Fisher Scientific.

¿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
    2015-08-11
  • 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
    A customer complaint triggered a technical investigation which confirmed that specific lots of t3462 broth, could produce out of specification high quality control results for the antibiotic tigecycline with the quality control organism enterococcus faecalis. further investigations identified that a different style of cap was used during the manufacture of a number of lots which could affect the seal on the vial and potentially result in oxygenation of the broth. the cap was also used for defined lots of cp11410 and cp112-10. therefore, all products that used the same cap and that could be used in conjunction with tigecycline, are being recalled. .

Device

Mueller-Hinton broth

Manufacturer

Remel Inc., part of Thermo Fisher Scientific