Events

Alerta De Seguridad para DISPOSABLE TECHNICAL NEEDLE FOR REGIONAL ANESTHESIA - Registration number 10033430144 - Lots: 6165445 and 6055445

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BECTON DICKINSON IND. CIR. LTDA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    855
  • Fecha
    2007-02-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    He declares that this difference in size is easily verified by the health professional. The Company declares that none of the reports received had an adverse event related to them as a result. If you have the above lots in your inventory, please contact your local representative or customer service department 0800 055 5456 - BECTON DICKINSON IND. CIR. LTDA
  • Causa
    The company received communication from some customers regarding the cannula of the needle spinal 22g 3-1 / 2 with reports that these were shorter than usual. according to the company, this demonstrates that some units of the spinal 22g 2-1 / 2 needle product have been erroneously identified as spinal 22g 3-1 / 2 needle.
  • Acción
    The Company analyzed the retention samples (30 units) and the reported fact was not verified in these units. BD made the decision to send a letter to all customers, reporting what happened and making available to replace the aforementioned lots.

Device

DISPOSABLE TECHNICAL NEEDLE FOR REGIONAL ANESTHESIA - Registration number 10033430144 - Lots: 616...

Manufacturer

BECTON DICKINSON IND. CIR. LTDA.
  • Source
    ANVSANVISA