Events

Alerte De Sécurité sur Protect-A-Line IV extension set

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

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
    2013-08-20
  • Date de publication de l'événement
    2013-08-20
  • 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_20130820a.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: vygon protect-a-line iv extension set the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning protect-a-line iv extension set (supplied with vented caps) manufactured by vygon. the affected product code is 0832.04 and all batch numbers ending in the letters ba are affected. according to the mhra, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps. identify affected devices. prior to use, remove vented caps from the female port (y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con306143 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.

Device

Protect-A-Line IV extension set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Vygon Protect-A-Line IV extension set
  • Manufacturer
    Vygon

Manufacturer

Vygon