Events

Avis De Sécurité sur SBK incision biopsy needle

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 Angiomed GmbH & Co. Medizintechnik KG.

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
    Through complaints, angiomed has identified products with the combinations of markings and batch numbers listed in annex 1 that may contain a mandrene cap at risk of breakage. if the mandrene cap broke, the user had to remove the needle and re-insert the new needle to complete the biopsy, or abandon the biopsy completely due to certain unforeseen circumstances. our records show that your establishment has purchased one or more units of affected products with combinations of labels and batch numbers. all other products with combinations of markings and batch numbers not listed in the safety corrective action notice may continue to be used at your establishment because they are safe to use and are not subject to this product recall.

Device

SBK incision biopsy needle

Manufacturer

Angiomed GmbH & Co. Medizintechnik KG