Events

Retiro De Equipo (Recall) de BD Vacutainer Multiple Sample Luer Adapter

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-2013-RN-00335-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-23
  • 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-2013-RN-00335-1
  • 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 received a number of following complaints relating to blood leakage when the vacutainer adapter is used in the blood collection process:1)the sleeve covering the np cannula - non-sleeve recovery, sleeve leakage, and sleeve fall off (pop-off). should such an event occur, there is an increased likelihood of blood leakage into the tube holder when a blood collection tube is removed from the tube holder (i.E. the sleeve fails to re-cover the np cannula allowing blood to leak into the tube holder). bd estimates that approximately 1.47% of the devices will be impacted by this issue.2)luer tip damage – small “nicks” or “flash” have been observed on the luer tip that connects to needles, blood collection sets, and infusion sets. should such a damaged device be used, there is an increased likelihood of blood leakage from the connection between the vacutainer adapter r and the access device. bd estimates that less than 1% of the devices will be impacted by this issue.
  • Acción
    BD is requesting customers to consider the risk of using a defective device in relation to their ability to maintain necessary blood collection procedures without the use of the BD Vacutainer Multiple Sample Luer Adapter. Should the customers choose to continue using the BD Vacutainer Multiple Sample Luer Adapter, BD is asking to ensure that all relevant staff are aware of the potential defects. BD also recommends that staff closely observe the luer tip of the device for potential damage. In the event that damage is observed, please instruct staff to discard the individual device. Should blood leak from the luer connection during blood collection please assess the need to conduct a re-draw, with a new luer adaptor, based upon the volume of blood within the tube (i.e. a low volume draw would require a re-draw). This action has been closed-out on 18/02/2016.

Device

BD Vacutainer Multiple Sample Luer Adapter
  • Modelo / Serial
    BD Vacutainer Multiple Sample Luer AdapterRef. No.: 367300All lot numbers manufactured starting with lot number 1354918 and afterARTG: 122153
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd