Events

Alerta De Seguridad O Notificaciones De Seguridad para Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Arrow® International.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2009/047
  • Número del evento
    CON052020
  • Fecha de publicación del evento
    2009-07-27
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON052020?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of leakage or air embolism due to hub cracking at the female luer connector during delivery of infusions containing lipids.Teleflex medical has determined that the material used in the manufacture of these stopcocks is not lipid resistant and could be weakened during the administration of lipid solutions. these stopcocks, and the kits containing them, should be used only to administer non-lipid containing solutions. teleflex originally issued a field safety notice (fsn) in march 2009 that highlighted these risks. however, the sample product label in this fsn carried an extra warning not to use 70% isopropyl alcohol on the stopcocks. after further testing, teleflex has determined that these stopcocks (distributed in the united kingdom) can in fact be wiped with 70% isopropyl alcohol solutions without harmful effects. as a consequence, teleflex has now issued an amended fsn in july 2009 with a revised product label.This medical device alert has been issued due to the widespread use of these stopcocks and to ensure that all users are aware of this amended field safety corrective action.

Device

Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resist...
  • Modelo / Serial
  • Descripción del producto
    Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by Arrow® The stopcocks are manufactured by Arrow® International, which is a subsidiary of Teleflex Medical. Product codes AH-05050-G, AI-07077-G, AH-05050-PU, AI-07077-PU (regardless of batch number) contain non-lipid resistant stopcocks.  Only product codes with batch numbers ZFxxxxxxx contain lipid resistant stop cocks. This is summarised in the table below: Product codes Lipid resistant batches Non-lipid resistant batches AH-05050-G None All AH-05050-PU AI-07077-G AI-07077-PU All product codes listed in Appendix A of the Field Safety Notice Lot numbers beginning with the letter ZF and followed by seven digits, e.g. ZFxxxxxxx. All other Lot numbers
  • Manufacturer
    Arrow® International

Manufacturer

Arrow® International