Events

Avis De Sécurité sur ARROW® Kits with BD Eclipse ™ Needles

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Arrow International.

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
    Field Safety Notice
  • Date
    2017-04-10
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    According to the contents of a letter from bd (copy attached), becton-dickinson (bd) has received reports on the removal of the safety cap and injuries from needle punching with a bd eclipse ™ needle. according to customer reports, in some cases, pushing the safety cover over the needle will cause it to fall off, resulting in needle exposure, which can increase the risk of injury from the needle stick. some customer reports state that a "click" is heard before the safety cap is locked (before it is activated), followed by a second "click" when the safety cap is locked over the needle. this can increase the risk of needle stick injuries if the user assumes that the safety cap is locked after the initial "click".

Device

ARROW® Kits with BD Eclipse ™ Needles

Manufacturer

Arrow International