Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MALLINCKRODT DO BRASIL LTDA.; Covidien..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1016
  • Date
    2010-04-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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

Device

KNIFE KNEE FOR TRACHEOSTOMY WITH SHILEY BALLOON (Anvisa Registry n ° 10139810076). List of affect...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.; Covidien.