Events

Alerta De Seguridad para 5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87, date of manufacture 03/2012, expiration date. 03/2017.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Descarpack Descartáveis do Brasil 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
    1277
  • Fecha
    2013-07-29
  • 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
    The company states that the foreign body identified in the syringe was in the packaging of the product, not in its interior, pointing out possible problem in the packaging process (referring to the use of personal protective equipment - PPE).
  • Causa
    According to the cvs - 40 - gt correlatos / ditep communiqué, dated april 22, 2013, the adolfo lutz institute issued the 1743.00 / 2013 analysis report and the single sample tax analysis expert report, with an unsatisfactory conclusion in the appearance (foreign body presence) for the product disposable syringe 5ml disposable descarpack, luer lock nozzle, registration no. 10330669025, lot: sslloo87, date of manufacture 03/2012, expiration date 03/2017.
  • Acción
    The company is collecting the product and asks users and patients to inform the SAC of the company, if they identify this lot of the product, by telephone (11) 3649-5555 and e-mail: sac.sc@descarpack.com .br ///////// UPDATE - 06/02/2014 - The company sent documentation informing about the completion of the field action and destruction of the collected units.

Device

5mL Disposable Syringe Descarpack, Luer Lock nozzle, Registration no. 10330669025, lot: SSLLOO87,...

Manufacturer

Descarpack Descartáveis do Brasil Ltda