Alerta De Seguridad para BBL MGIT Mycobacteria Indicator Tube (reg 10033430437), BBL MGIT 960 PZA Medium (reg 10033430381), BBL MGIT Mycobacteria Growth Indicator Tube (reg 10033430437).

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 and Company.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    The manufacturer of the products in the United States of America, Becton Dickinson and Company, received a limited number of complaints (5 complaints between 2003 and 2008) reporting the presence of cracks in culture media tubes for mycobacteria detection. In only one case was found leaking of the medium after inoculation. Becton Dickinson cautions against the fact that pathogenic microorganisms, including hepatitis B virus and acquired immunodeficiency virus (HIV), may be present in clinical samples, which makes the presence of cracking in the tubes of these products a risk factor for the user. According to the company, before using culture medium vials, the user should carefully examine the vials for evidence of contamination or damage - if any problem is verified, the tube should be discarded immediately. The Technovigilance Unit is following up on this case.
  • Causa
    Possibility of presence of cracks in culture medium tubes for the detection of microorganism mycobacterium tuberculosis.
  • Acción
    The company Beckton Dickinson Industries Surgical Ltda. Requests that the use of the above mentioned products be interrupted and that the remaining quantities be returned to the company, to perform visual inspection in 100% of the products marketed. According to the company, the existing stock in the market will be replaced by boxes with 100% of the pipes inspected.


  • Source