Events

Alerte De Sécurité sur Hudson RCI One-Way Valve with Capped Monitoring Port

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Teleflex 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
    2018-04-13
  • Date de publication de l'événement
    2018-04-13
  • 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_20180413a.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: teleflex medical hudson rci one-way valve with capped monitoring port therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning hudson rci one-way valve with capped monitoring port [product code number: 1644; lot number: 74k1502092 and 74k1601936], manufactured by teleflex medical. it has been identified by the manufacturer that one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. to date, there have been no injuries reported as a result of this issue. according to the manufacturer, disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death. the users are advised to immediately discontinue use and quarantine any products of the affected lot numbers. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00307-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 april 2018.

Device

Hudson RCI One-Way Valve with Capped Monitoring Port
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Teleflex Medical Hudson RCI One-Way Valve with Capped Monitoring Port
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical