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Notificaciones De Seguridad De Campo acerca de Neria Steel Cannula Infusion sets
Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Unomedical a/s.
¿Qué es esto?
Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.
Más información acerca de la data acá-
Tipo de evento
Field Safety Notice
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Número del evento
SN2012(12)
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Fecha
2012-08-21
- País del evento
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Fuente del evento
HPRA
- URL de la fuente del evento
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Notas / Alertas
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland." -
Notas adicionales en la data
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Causa
There is a risk that the needle of the neria steel cannula infusion set may break during use leading to leakage of medication and the potential need for surgical intervention to remove the needle.
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Acción
1. Ensure that the relevant personnel in your organisation are made aware of this issue. 2. Determine whether you have purchased a device that could be affected by this issue by reviewing the attached FSN. 3. Ensure that all users of these devices are aware of the information supplied by the manufacturer in the attached FSN to ensure safe use of the devices.
Device
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Modelo / Serial
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Descripción del producto
Neria Steel Cannula Infusion sets manufactured by Unomedical
- Manufacturer
Manufacturer
- Empresa matriz del fabricante (2017)
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Source
HPRA