Alerta De Seguridad para BD VACUTAINER PLASTIC TUBE WITH REAGENT FOR BLOOD COLLECTION - Record Number: 10033430261 - Venc. Record: 5/26/2010

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 INDÚSTRIA CIRÚRGICA 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
  • 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 Company informs that products will be collected and their units replaced. According to the Company's own information, this notice does not apply to SST II Advance gel tubes, cat 367955, 367957 and 367958, manufactured in Plymouth - UK. Its use should not be discontinued. For more information, contact the CRC Customer Relationship Center - Telephone: 0800 055 5654. Anvisa through the Technovigilance Unit will be accompanying the case, in order to ensure that health products marketed in Brazil have the security and the effectiveness necessary to the good performance of the product. ////// UPDATE: On January 11, On 02/26/2007, the Company informed that it informed the 160 customers that they had purchased the lots involved and received 110 customer response forms from them. Of the 110 respondents, only 18 declared a need to exchange the product, and the process was already finalized in 13 clients. On January 25, 2008, the company updated the recall stating that of the 160 customers contacted, three did not return the response form stating whether or not the product was in stock and at the time of the recall, only 17 customers still maintained the product. The exchanges were made. In mid-December 2006 the investigation was completed and the tubes that were blocked in the company's stock were destroyed in March / 2007, September / 2007 and December / 2007. The company considers that all the actions were taken and the recall was considered finished.
  • Causa
    Report of a supposed problem involving the cork of some units that is involuntarily detached from everything during use. sst catalog ii 3.5 ml - cat 367381 - lots involved: 602590e.603919e, 604546e, 605591e, 608944e, 616034e, 616035e, 616036e, 617066e, catalog sst ii 5.0 ml - cat 367382 - lots involved: 602705e, 606597e, 616555e, 617392e, 617945e, 618467e, 618990e, 619371e, 620776e, 621539e, 622343e, 607266e.
  • Acción
    The Company informs the voluntary collection of GEL SST II NATIONAL MANUFACTURING TUBES - CATALOGS: 367381 and 367382. REQUIRED ACTIONS: Identify if your institution is using or has stock of Plastic GX SST II Blood Collection Plastic Tube National manufacture, catalog 367381 / Gel SST II - 3.5 ml or 367382 - Gel SST II - 5.0 ml. Discontinue use immediately and lock the stock.