Events

Alerte De Sécurité sur Neonatal Endotracheal Tube SCP Clamp/Holders

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Capatex 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
    2012-05-25
  • Date de publication de l'événement
    2012-05-25
  • 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_20120525.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: capatex neonatal endotracheal tube scp clamp/holders the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning neonatal endotracheal tube scp clamp/holder manufactured by capatex medical. the manufacturer is recalling the products prior to batch 1002854. according to the mhra, a change was made to the composition of the plastic material used, to make the clamps/holder dehp-free. this affected the physical properties of the clamps, resulting in an increased risk of slippage. to counteract this, capatex added an extra notch on the clamp. however, this introduced the possibility of over-tightening and occlusion of the internal diameter of the endotracheal tube. as a result, there is a risk of airway loss due to slippage or airway obstruction. the manufacturer recommended that checks must be made to ensure the endotracheal tube is not slipping or being compressed. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/ index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 25 may 2012.

Device

Neonatal Endotracheal Tube SCP Clamp/Holders
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Capatex Neonatal Endotracheal Tube SCP Clamp/Holders
  • Manufacturer
    Capatex Medical

Manufacturer

Capatex Medical