Events

Rappel de Left Double Lumen Endobronchial Tube with Parker Flex-Tip

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

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
    RC-2017-RN-00258-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-03-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00258-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    An overseas complaint has been received from a physician where the product was not functioning as intended for single lung ventilation. the physician had an experience where after full intubation isolation was not successful when the physician turned the patient on his side to begin the procedure. the physician’s supposition was that the anatomy of the patient shifted in a way that occluded the bronchial lumen and prevented continued lung isolation. the physician replaced the endobronchial tube with another product and completed the procedure. to date, there has been no patient injury or harm.
  • Action
    Device Technologies Australia (DTA) is requesting customers to immediately cease the use of affected devices. Customers are further requested to inspect and quarantine affected stock prior to their return to DTA for a replacement.

Device

Left Double Lumen Endobronchial Tube with Parker Flex-Tip
  • Modèle / numéro de série
    Left Double Lumen Endobronchial Tube with Parker Flex-TipProduct Codes: WL-I-PFTDL-28, WL-I-PFTDL-32, WL-I-PFTDL-35, WL-I-PFTDL-37, WL-I-PFTDL-39 and WL-I-PFTDL-41Batch Numbers: 608DL1325A, 608DL1325B, 608DL1325C, 608DL1325D, 608DL1325E and 608DL1325F ARTG Number: 170268
  • Classification du dispositif
    Anesthesiology Devices
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd