Events

Alerta De Seguridad para Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 381434, (5) 381437, (6) 381444, (7) 381447, (8) 381454, (9) (11) 381523, (12) 381533, (13) 381534, (14) 381544;

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BD Infusion Therapy Systems.

¿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
    179
  • Fecha
    2000-02-24
  • 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
    BRAZIL-21.12.2001. The company reports that on September 18, 2001, Becton Dickinson & company; through its BD medical systens division, notified the FDA that it had identified through its own controls that batches 106170 and 108010 of the catheter insyte autoguard product, manufactured in its the sandy, utah-usa plant had micro-holes in the primary packaging. In order to prevent potential risks of adverse effects, the company voluntarily decided to collect these lots from the market. He also reports that no notification was sent to foreign governments by Becto Dickison's subsidiary due to the fact that the product was exclusively distributed on the American market.
  • Causa
    Lots nos .: (1) 909170, 910152, 910171, 911151, 911164, 912160; (2) 909166, 909169, 909179, 909172, 909172, 909172, 909181, 910153, 910163, 910163, 910170, 910172, 910175, 910180, 910186, 911187, 911167, 911161, 911163, 911166, 911173, 911177, 912153, 912155, 912158, 912161 , 912165, 912174, 912180, 912183, 001152, 001157, 001163, 001171; (3) 909173, 910151, 910154, 911158, 912151, 912167; (4) 907176, 907177, 908166, 908175, 908176, 909152, 909165, 910157, 910173, 910177, 910182, 911153, 911154, 911169, 911172, 911182, 911185, 912156, 912164, 912166, 912171, 912173, 912176, 912182 , 001151, 001158, 001170; (5) 911176; (6) 909178, 910162, 910164, 910174, 910176, 910179, 911156, 911159, 911165, 911178, 911180, 912152, 912159, 912162, 912169, 912177, 001153, 001159, 001164, 001172; (7) 910169, 912172; (8) 910156; (9) 910167; (10) 910166, 910178, 911168, 911175, 912168; (11) 908177, 910161, 910183, 911179, 912154, 912185, 001162; (12) 910181, 911152, 912157; (13) 908172, 909179, 910165, 911155, 911170, 912179, 001160; (14) 910184, 911171, 912175 the mentioned catheters may cause epithelial irritation at the catheter insertion sites. the manufacturer initiated a mail-order and visit removal, shipped on february 23 and 24, 2000.
  • Acción
    Make sure that you have been contacted by BD Infusion Therapy Systems. Identify and isolate any affected product from your inventory. Contact BD Infusion Therapy Systems at the address listed to make arrangements for returning the product and obtaining the replacement product. For more information, contact your local BD representative or Rand Pugmire, recall coordinator, at (801) 565-2550 in the United States.

Device

Insyte AutoGuard Intravenous Catheters; In the Catalog. (1) 381412, (2) 381423, (3) 381433, (4) 3...

Manufacturer

BD Infusion Therapy Systems
  • Source
    ANVSANVISA