Events

Alerta De Seguridad para Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Teleflex Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-09-02
  • Fecha de publicación del evento
    2015-09-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150902b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    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