Events

Alerta De Seguridad para Short Term Acute Dialysis Catheters

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

¿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
    2013-06-17
  • Fecha de publicación del evento
    2013-06-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130617a.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: joline short term acute dialysis catheters the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning short term acute dialysis catheters, manufactured by joline. the affected products were manufactured from jun 2012 to feb 2013. in the course of continuous market surveillance, the manufacturer became aware that occasionally there could be an increased risk of hairline cracks at the connectors of these catheters. it was observed that during the application of the catheter crack formation sporadically occurred. although there has been no patient endangering so far, blood loss cannot be excluded. by means of optimized manufacturing processes and improvements of the design, the mechanical and chemical resistance could be enhanced. until these measures are completely implemented, the manufacturer asks customers to waive alcoholic disinfectants, in no case connect before complete drying as already indicated in the instructions for use and avoid excessive forces when connecting as well as ensure a regular and frequent control of the connectors, and securely clamp affected catheters with the mounted safety clamp and change the catheter. furthermore, the manufacturer advises distributors to stop selling the affected products. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286760 if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 june 2013.

Device

Short Term Acute Dialysis Catheters
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Joline Short Term Acute Dialysis Catheters
  • Manufacturer
    Joline

Manufacturer

Joline