Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MALLINCKRODT DO BRASIL LTDA.; Covidien..

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Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

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  • Type d'événement
    Safety alert
  • ID de l'événement
    1016
  • Date
    2010-04-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.