Events

Avis De Sécurité sur Broviac Paediatric Catheter

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Becton, Dickinson and Company.

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
  • Numéro de l'événement
    SN2003(01)
  • Date
    2003-02-13
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/broviac-paediatric-catheter&id=fc91f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The imb has been advised of several incidents with patients on long-term total parenteral nutrition using a broviac paediatric catheter.  defects developed at a similar point on the catheter, where the hub separated from the catheter.
  • Action
    The IMB advise that users of this product:  Ensure that all staff dealing with broviac lines are advised of the incidents that have arisen with this device.   Advise all staff and family members dealing with the device to carry out regular inspections of the device.   Ensure that all staff and family members are trained in the use of the catheter. Ensure the device is clamped at the points indicated by the manufacturer in their literature.   Report any indication of problems with the device to the Irish Medicines Board

Device

Broviac Paediatric Catheter

Manufacturer

Becton, Dickinson and Company