Events

Rappel de BD Q-SYTE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    38430
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-02-18
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    May fail to conform to a claim made by the manufacturer or importer relating to its performance and may be hazardous to health: the silicone column of the septum of the bd q-syte luer access split septum device is torn resulting in leakage of blood or infusate from the side holes or the remote potential for air bubbles to enter into the bloodstream if a negative pressure/vacuum situation is created. date the event was first identified: december 24 2014. description of how the event was identified: an increase in the number of complaints for this product was identified internally. note that there have been no complaints for air in the line related to the use of the device with a peripheral iv or a cvc line. there have also been no complaints for this product from canadian customers.

Device

BD Q-SYTE
  • Modèle / numéro de série
    Model Catalog: 385100 (Lot serial: 4128926)
  • Description du dispositif
    BD Q-SYTE LUER ACCESS SPLIT SEPTUM
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.