Events

Retiro De Equipo (Recall) de BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00728-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00728-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Bd has become aware that some lots of the bd vacutainer eclipse signal blood collection needle with integrated holder (catalogue numbers 368835 and 368836) have the potential for the integrated holder to become detached from the needle. this detachment can lead to possible sample collection failure, and in exceptional circumstances, have the potential to cause a needle stick injury. the manufacturer has estimated that the frequency of this failure mode is 0.198%.
  • Acción
    BD is providing instructions to allow the continued use the Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder: - Prior to use, ensure that the pink Eclipse Shield is positioned over the green or black needle cover. Grasp the needle cover and pink Eclipse Shield together and the holder in the other hand and pressing firmly down on the pink Eclipse Shield pull in a straight direction. Do not bend the device whilst pulling. - If the holder becomes detached, dispose of the device in an appropriate sharps collector. This action has been closed-out on 17/08/2016.

Device

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G
  • Modelo / Serial
    BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21GCatalogue Number : 368835 Lot/Batch Numbers4302105 4266252 4302106 4276343 4346490 4344023 4252010 5041109 4259413 5072433 22G Catalogue Number :368836 Lot/Batch Numbers 4268488 4346068 4302103 5027368 4346062ARTG Number: 128397
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd