Events

Avis De Sécurité sur BD Plastipak Syringes / BD 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 GmbH.

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
    2015-09-30
  • 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
    We have received reports from us customers of decreased potency when drugs are compounded or repackaged and stored in bd plastipak syringes. because of the potential public health impact when the syringes are used in this way, we are issuing this communication to assist in identifying affected syringes. .

Device

BD Plastipak Syringes / BD Oral Syringes
  • Modèle / numéro de série
    Dates (MM/YYYY) Lot Details Luer-Lok™ syringe 309658 8/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301073 10/2014-06/2015 Refer to bd.com/alerts-notices Oral syringe 305210 305220 305853 03/2014-05/2015 Refer to bd.com/alerts-notices Luer-Lok™ syringe 309649 08/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301027 08/2012-07/2015 Refer to bd.com/alerts-notices With BD Eclipse™ needle 305785 03/2012 - Present Refer to bd.com/alerts-notices With BD SafetyGlide™ needle 305907 03/2011 - Present Refer to bd.com/alerts-notices Oral syringe 305855 305218 07/2014-07/2015 Refer to bd.com/alerts-notices 300613 301183 301190 Bulk non sterile Eccentric Tip syringe 300220 07/2013-Present Refer to bd.com/alerts-notices 30mL Luer-Lok™ syringe 302832 01/2013-07/2014 Refer to bd.com/alerts-notices Catheter Tip 300867 06/2013 - Present Refer to bd.com/alerts-notices Bulk non sterile catheter tip 300228 08/2014- Present Refer to bd.com/alerts-notices 5mL 20mL Eccentric Tip syringe 01/2015-Present Refer to bd.com/alerts-notices 50mL 3 ml With BD SafetyGlide™ needle 305904 09/2012 - Present Refer to bd.com/alerts-notices Syringe Size Product Type Catalog No. Produced with Alternate Stopper
  • Manufacturer
    Becton Dickinson GmbH

Manufacturer

Becton Dickinson GmbH