Events

Retiro De Equipo (Recall) de Beckton Dickinson PrepMate™ Vial Cap

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 manufacturer #1479.

¿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
    19800
  • Fecha de inicio del evento
    2016-02-24
  • 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
    The prepmate™ vial cap is the spare lid sold separately to re-seal the bd surepath™ collection vial post processing., some prepmate™ vial caps are cracked on the top and have the potential to cause leakage., the concern with any leakage from the vial after specimen collection is that it could cause irritation or inflammation to skin or mucous membranes since there is an increased risk of chemical or biological exposure. cytological specimens may contain infectious agents. if there is contact due to leakage or splashing (preservative fluid contains 24% ethanol and <1% formaldehyde), it can also cause temporary (non-permanent) vision issues.
  • Acción
    Product to be destroyed

Device

Beckton Dickinson PrepMate™ Vial Cap
  • Modelo / Serial
    Model: 490505, Affected: Lot Nosd: 5029674 5051867 5083935 5117563 5176869 5202623 5198835
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479