Events

Alerta De Seguridad para AMED Mucus Trap 40cc

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

¿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
    2016-04-06
  • Fecha de publicación del evento
    2016-04-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160406c.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: jiangsu rongye technology amed mucus trap 40cc the hospital authority (ha) of hong kong issued a press release on 5 april 2016 concerning amed mucus trap 40cc, manufactured by jiangsu rongye technology co ltd. [model number: k1023; lot number: 1503b006]. seven bronchoscopy cytology specimens, collected from 1 march 2016 among a group of patients in the medical department of ruttonjee and tang shiu kin hospital, were confirmed positive for non-viable fungus. the hospital later formed an expert panel to conduct an investigation on this issue. the panel conducted thorough investigation on the environment of the hospital, bronchoscopy appliances as well as infection control procedure to identify the root cause. the panel finally found similar non-viable fungus in the abovementioned mucus traps. to ensure patient safety, the hospitals concerned had immediately suspended the use of the affected mucus traps and followed up with the supplier for recall and substitutes from other suppliers. for details, please refer to the ha’s press release: http://www.Info.Gov.Hk/gia/general/201604/05/p201604050852.Htm if you are in possession of the affected products, please contact your supplier for necessary actions posted on 6 april 2016.

Device

AMED Mucus Trap 40cc
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Jiangsu Rongye Technology AMED Mucus Trap 40cc
  • Manufacturer
    Jiangsu Rongye Technology Co Ltd.

Manufacturer

Jiangsu Rongye Technology Co Ltd.