Alerta De Seguridad para KNIFE KNEE FOR TRACHEOSTOMY WITH SHILEY BALLOON (Anvisa Registry n ° 10139810076). List of affected products available at http://portal.anvisa.gov.br/wps/wcm/connect/aff6ed80422df0209b12ff01cce3dc94/Lista+de+Produtos+Afetados.pdf?MOD=AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MALLINCKRODT DO BRASIL LTDA.; Covidien..

¿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
    1016
  • Fecha
    2010-04-19
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    Abroad, some of the manufacturer's clients reported serious adverse events, which may be related to Shiley cuff tracheostomy tubes - the cuff does not retain leaking air in the inflation envelope of the pilot balloon. The codes affected by the recall in the Brazilian market are listed in the Product Description field of this alert. Batch numbers are formed by the sequence AAMMXXXXXX, where AA is the year, MM is the month, and XXXXXX is a sequential number.
  • Causa
    The cuff of the tracheostomy tube does not retain air from leaks in the pilot balloon inflation set. if the cuff does not retain air, ventilation is adversely affected and immediate tube replacement may be necessary for tracheostomy.
  • Acción
    The product registration holder in Brazil is collecting the affected lot numbers from Shiley Tracheostomy Products. Product users should check their inventory and separate any product from the batch numbers that have been affected. Affected products that have not yet been used should be returned according to the instructions given below: If a Shiley cuff tracheostomy tube of one of the affected batches is already being used in a patient, it is recommended that the tube be replaced by a tube of some lot that has not been affected, so the doctor responsible for the patient judges clinically appropriate. If the physician advises that the tracheostomy tube is maintained until there is a more acceptable replacement opportunity, it is strongly recommended that the frequency and intensity of monitoring of the cuff inflation system be increased. To return the affected product and obtain refund, you must contact Covidien's Customer Service department at 0800-1780170 or email atendimento.brasil@covidien.com. If the product was purchased from a distributor, the user should contact their supplier to follow the due return procedure. Companies that have distributed products whose codes are listed to other persons or units should immediately forward a copy of this notice to such persons or units. To check the codes and batches of the affected products, access http://portal.anvisa.gov.br/wps/connect/aff6ed80422df0209b12ff01cce3dc94/Lista+de+Produtos+Afetados.pdf?MOD=AJPERES

Manufacturer