Events

Notificaciones De Seguridad De Campo acerca de BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por BD Diagnostics Preanalytical Systems.

¿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
  • Número del evento
    SN2014(09)
  • Fecha
    2014-02-28
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bd-vacutainer-multiple-sample-luer-adaptor.-catalogue-number-367300&id=bc77f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
  • Causa
    Bd diagnostics preanalytical systems have received an increase in reports of blood leakage when using the bd vacutainer® multiple sample luer adaptor. the blood leakage is attributed to the retractable non-patient cannula (grey) showing non sleeve-recovery, sleeve leakage or sleeve fall-off. bd has also received reports detailing blood leakage at the luer tip connection end, which has the potential to lead to evacuated blood collection tubes not being filled completely.  these issues can lead to an increased risk to users of exposure to blood and a risk of under-filling of blood collection tubes which could lead to unexpected results in some laboratory tests. no adverse incidents of accidental blood exposure or under-filling of the tubes involving the bd vacutainer® multiple sample luer adaptor have been reported to the imb.
  • Acción
    he IMB advises that users:  (1) Identify affected lots and ensure that all relevant staff are aware of the recommended actions in the manufacturer’s FSN.  (2) Distribute this notice to healthcare professionals in your organisation who may use the BD Vacutainer® Multiple Sample Luer Adaptor (Product Ref: 367300) and maintain awareness of this safety notice for an appropriate time period.  (3) Complete and return the FSN acknowledgement to BD to indicate receipt and transmission of this FSN in your organisation.  (4) If you have distributed the devices to other healthcare professionals or organisations, forward this notice to those healthcare professionals and organisations.  (5) BD will replace products from affected lot numbers on request. Contact BD for replacement product, if required.

Device

BD Vacutainer Multiple Sample Luer Adaptor. Catalogue number: 367300

Manufacturer

BD Diagnostics Preanalytical Systems