Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Becton, Dickinson And Company.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 133 05 18 000
  • Date de mise en oeuvre de l'événement
    2018-05-30
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12689
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Bd states that it has received reports of users experiencing difficulty or failing to prime the above administration sets. the pump administration sets require priming before patient use as described in the directions for use. bd also states that it is during the priming process that this problem can be observed. during priming, when attempting to fill the drip chamber, the drops into the drip chamber will not be observed once the roller clamp is opened. bd further states that this problem is highly detectable.

Device

BD SmartSite Administration Sets
  • Modèle / numéro de série
    10015489, 11426965, 2120-0500, 2420-0007, 2420-0500
  • Description du dispositif
    Infusion Pump Administration Sets
  • Manufacturer
    Becton, Dickinson And Company

Manufacturer

Becton, Dickinson And Company