Events

Notificaciones De Seguridad De Campo acerca de BD Plastipak Syringes / BD Oral Syringes

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 Becton Dickinson GmbH.

¿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
    2015-09-30
  • 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
    We have received reports from us customers of decreased potency when drugs are compounded or repackaged and stored in bd plastipak syringes. because of the potential public health impact when the syringes are used in this way, we are issuing this communication to assist in identifying affected syringes. .

Device

BD Plastipak Syringes / BD Oral Syringes
  • Modelo / Serial
    Dates (MM/YYYY) Lot Details Luer-Lok™ syringe 309658 8/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301073 10/2014-06/2015 Refer to bd.com/alerts-notices Oral syringe 305210 305220 305853 03/2014-05/2015 Refer to bd.com/alerts-notices Luer-Lok™ syringe 309649 08/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301027 08/2012-07/2015 Refer to bd.com/alerts-notices With BD Eclipse™ needle 305785 03/2012 - Present Refer to bd.com/alerts-notices With BD SafetyGlide™ needle 305907 03/2011 - Present Refer to bd.com/alerts-notices Oral syringe 305855 305218 07/2014-07/2015 Refer to bd.com/alerts-notices 300613 301183 301190 Bulk non sterile Eccentric Tip syringe 300220 07/2013-Present Refer to bd.com/alerts-notices 30mL Luer-Lok™ syringe 302832 01/2013-07/2014 Refer to bd.com/alerts-notices Catheter Tip 300867 06/2013 - Present Refer to bd.com/alerts-notices Bulk non sterile catheter tip 300228 08/2014- Present Refer to bd.com/alerts-notices 5mL 20mL Eccentric Tip syringe 01/2015-Present Refer to bd.com/alerts-notices 50mL 3 ml With BD SafetyGlide™ needle 305904 09/2012 - Present Refer to bd.com/alerts-notices Syringe Size Product Type Catalog No. Produced with Alternate Stopper
  • Manufacturer
    Becton Dickinson GmbH

Manufacturer

Becton Dickinson GmbH