Events

Avis De Sécurité sur BD Eclipse™ Injection Needle and others

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 BD.

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
  • 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
    Bd has received reports of safety cover/shield disengagement, which has the potential to lead to a needlestick injury (nsi) when using the bd eclipse™ injection needle and bd preset™ eclipse™ arterial blood collection syringes. based on the customer reports, in some cases when the safety cover/shield is pushed over the needle it disengages, resulting in an exposed needle which can increase the risk of nsi. some customer reports indicate an audible “click” sound before the safety cover/shield is locked (activated) followed by a second “click” sound when the safety cover/shield is locked over the needle. this may potentially increase the risk of nsi if the user assumes the safety cover/shield is locked after the initial “click”. .

Device

BD Eclipse™ Injection Needle and others
  • Modèle / numéro de série
  • Manufacturer
    BD

Manufacturer

BD