Events

Alerte De Sécurité sur Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack

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
    2015-09-02
  • Date de publication de l'événement
    2015-09-02
  • 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_20150902b.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 flexi-slip endotracheal tube stylet with soft distal tip and flexislip stylet, sterile pack the medicines & healthcare products regulatory agency (mhra) has issued a medical device safety alert concerning flexi-slip endotracheal tube stylet with soft distal tip (product code: 502501) and flexislip stylet sterile pack (product codes: 503700-000060, 503700-06) manufactured by teleflex medical. the manufacturer has received reports of the plastic coating of the stylet splitting and/or breaking off of the stylet. this may result in a piece of plastic totally or partially occluding the patient’s airway and impairing ventilation, or necessitating invasive removal procedures in order to prevent complications such as atelectasis or pneumonia. according to the manufacturer, no patient injuries have been reported related to this issue. users are advised to quarantine and cease use of the affected products. for details, please refer to the tga website:https://mhra.Filecamp.Com/public/file/29qi-f3qkkkq2 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 2 september 2015.

Device

Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Teleflex Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical