Events

Notificaciones De Seguridad De Campo acerca de pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Merck Serono.

¿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
  • Número del evento
    SN2014(24)
  • Fecha
    2014-05-09
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ph-indicator-strips-(non-bleeding)-ph-0-6.0-2.0-9.0-priority-2-warning-caution-in-use&id=d2cef925-9782-6eee-9b55-ff00008c97d0
  • 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
  • Causa
    A communication issued by merck serono to irish customers in may 2013 indicated that an additional ‘safety feature’ had been introduced for these products, to facilitate their use in non-buffered solutions.  merck serono has informed the irish medicines board (imb) that the safety feature introduced in 2013 does not function as intended over the lifetime of the product.  the manufacturer has issued the attached field safety notice (fsn) to users of these devices to reiterate that these devices should only be used with gastric aspirate. merck serono is also implementing a revision to the instructions for use (ifu) for their ph indicator strips in order to strengthen the warning regarding use with low buffered solutions.  the imb wishes to remind users to use these devices with caution.
  • Acción
    The IMB advises users:  (1) Merck Serono pH Indicator strips (0-6.0 product code 090120604 and 2.0-9.0 product code 090120603) should be used with caution.  a. These strips are only for use with gastric aspirate  b. These strips are not suitable for use with low buffered solutions  c. These strips are not suitable for use with any kind of water (distilled, sterilised, potable, bottled or tap water)  (2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice on to any end users or organisations where these devices may have been distributed.

Device

pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0
  • Modelo / Serial
  • Descripción del producto
    pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 Priority 2 – Warning Caution In Use
  • Manufacturer
    Merck Serono

Manufacturer

Merck Serono
  • Empresa matriz del fabricante (2017)
    Merck KGaA
  • Source
    HPRA