Events

Alerte De Sécurité sur insulin infusion 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 Cellnovo.

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
    2014-07-15
  • 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_20140715.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
    Press release
  • Cause
    Safety alert on cellnovo insulin infusion set the department of health (dh) today (july 15) warned the public not to use the infusion set 5mm stainless steel (part no.: 5mm-inf5) and infusion set 8mm stainless steel (part no.: 8mm-inf5), manufactured by cellnovo, because of the possibility that the stainless steel needle may detach itself. the dh, through its routine surveillance of medical devices, noticed the safety alert from the medicines and healthcare products regulatory agency (mhra) of the united kingdom. according to the alert, there is a remote possibility that the stainless steel needle may detach itself while the patient is attempting to remove the infusion set during the changeover to a new insulin cartridge. the detachment of the needle does not pose a risk to safety, however it may not be possible for the patient to remove the needle without seeking professional medical assistance. the alert indicated that the manufacturer will supply the patient with new replacement infusion sets. patients are advised to pass the entire stock of unused infusion sets to the manufacturer for safe and correct disposal. the dh is checking with the manufacturer whether the affected products have been distributed to hong kong. no adverse incident related to the affected products has been reported in hong kong so far. if you are in possession of the products, please contact your supplier for necessary actions. the dh has informed the hospital authority, private hospitals and relevant medical professional associations about the matter and advised them to remain vigilant. the spokesman said, "the dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt." ends.

Device

insulin infusion set
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert on Cellnovo insulin infusion set
  • Manufacturer
    Cellnovo

Manufacturer

Cellnovo