Events

Alerte De Sécurité sur Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Smiths Medical.

Qu'est-ce que c'est?

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.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-04-20
  • Date de publication de l'événement
    2015-04-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150420.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: smiths medical portex bivona inner cannula for bivona adult tracheostomy tubes medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its portex bivona inner cannula for bivona adult tracheostomy tubes [model/catalogue numbers: brc270, brc275, brc280, brc285, brc290, brca70, brca75, brca80, brca85, brca90; all lot numbers]. the manufacturer has become aware of the potential for compression of the inner cannula to occur as a result of handling or certain cleaning methods used with inner cannulae. compression can result in a shorter overall length. use of an inner cannula which is too short may lead to a build-up of secretions within the end of the tracheostomy tube which may cause infection or occlusion. the inner cannula should be handled and cleaned with care, and according to the instructions for use (“ifu”). according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 april 2015.

Device

Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical