Events

Avis De Sécurité sur BD Plastipak / Oral Syringes

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 Becton Dickinson UK Limited.

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
    2016-11-16
  • 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 communicated in september 2015, via an urgent field safety notice (mss-15-637 fa) that customers had reported reduced potency of certain medications when stored in bd plastic disposable syringes, made with a stopper provided by an alternate supplier. the purpose of this follow-up is to inform our customers about the corrective actions implemented by bd: 1- all syringes currently distributed in ireland by bd are manufactured with a stopper provided by our primary supplier (not affected by the issue), except for the 4 products listed in table a. 2- the syringes in table a are currently manufactured with the stopper from the alternate supplier and are still in distribution in ireland. 3- bd is committed to converting all syringes sold in the eu back to the primary stopper supplier and expects that from july 2017, all syringes supplied to the marketplace will contain the primary stopper only. .

Device

BD Plastipak / Oral Syringes

Manufacturer

Becton Dickinson UK Limited