Events

Alerta De Seguridad para BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041

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 INDÚSTRIAS CIRÚRGICAS 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
    1619
  • Fecha
    2015-07-03
  • 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 PrecisionGlide needle is made from stainless steel, plastic resins, glue and silicone. Essentially, each of these materials is stable and must provide mechanical stability to the product even after the expiration date. The risk with the product is related to the barrier of the sterile packaging. If the package degrades after the expiration date, this may result in a breach of the sterile barrier. No reports of adverse events related to the use of this product have yet been received after expiration.
  • Causa
    In june 2015, the bd company was notified that, as a result of a mixture of lots at the warehouse of sanofi-aventis farmacêutica ltda., 5,016 units of precisionglide needle 0.60 x 25mm lot 9149041 were dispatched and delivered together with lot 3056430 . the expedition took place in june / 2015. from that same lot (lot 9149041) 3,057 needles were dispatched and delivered together with the lot. in this case the shipment occurred between january / 2013 and july / 2014. the investigation carried out by bd brasil and sanofi showed that the mixture occurred in the logistic operator of the warehouse of the company sanofi, where the lots were stored in the same pallet position and later delivered in bonus to the customers who purchased the adacel vaccine. therefore, this notice only affects healthcare institutions that eventually physically received lot 9149041 as part of the bonus linked to the acquisition of adacel (single-dose vial vaccine). lot 9149041 has expired expiration date.
  • Acción
    Some users of the Adacel Vaccine received mixed batches. So this alert and your actions are focused on this audience. Sanofi advised customers that they received the batches of PrecisionGlide Needle affected by this mix by sending a letter, directing them to take the following actions: 1. Immediately conduct the inventory survey to identify and segregate lot 9149041; 2. Do not use any unit of lot 9149041; 3. Contact Sanofi Pasteur through Telesales 0800 11 90 20 or by e-mail televendas.brasil@sanofipasteur.com

Device

BD PrecisionGlide Hypodermic Needle, registration no. 10033430019 - lot 9149041

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.