Events

Retiro De Equipo (Recall) de Beckton Dickinson Vacutainer Multiple Sample Luer Adaptor

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por BD Medical (USA).

¿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
    14561
  • Fecha de inicio del evento
    2013-04-26
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    Manufacturer has received a number of complaints relating to blood leakage when the bd vacutainer multile sample luer adapter is used in the blood collection process. these complaints relate to:, 1. the sleeve covering the np cannula, 2.Luer tip damage., due to current stocks holdings both locally and globally and existing demands bd is unable to substitute product for the bd vacutainer multiple sample luer adapter. should a defective device be used bd is providing information (product correction ) regarding the use of the device ., bd recommends that staff closley observe the luer tip of the device for potential damage. in the event that damage is observed staff are instructed to discard the individual device. should blood leak from the luer connection during blood collection ases the need to conduct a re-draw with a new luer adaptor, based upn the volume of blood in the tube.
  • Acción
    Manufacturer to issue advice regarding use

Device

Beckton Dickinson Vacutainer Multiple Sample Luer Adaptor
  • Modelo / Serial
    Model: 367300, Affected: all lot numbers manufactured starting with lot number 1354918 and after
  • Manufacturer
    BD Medical (USA)

Manufacturer

BD Medical (USA)