Events

Rappel de Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Procedure Packs)Frazier Suction Handle

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medline International Two 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-2018-RN-00104-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-05
  • 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-2018-RN-00104-1
  • 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
    Medline has been made aware of overseas complaints from users regarding swivelling of the suction tip of the handle of these devices. depending on the type of procedure, there is a potential for serious harm such as delayed recovery/delay in treatment, and tissue damage. it is very likely that the user may still be able to continue suctioning even after the suction tip starts to swivel within the handle. the chances of detecting the swivel by the user remain high.No complaints for this issue have been received to date in australia. no patient harm has been reported as a result of this issue.
  • Action
    Medline is advising users to inspect the Frazier suction handle for a loose tip prior to use. Additional/alternative Frazier units may be kept on standby just in case users experience swivelling of the suction tip. The manufacturer is currently validating a revised manufacturing process after shifting the bending fulcrum of the bending fixture from the handle to the metal tube thus reducing the impact of the bending force on the handle. After successful validation and product testing, the revised product will be introduced to the market.

Device

Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Proc...
  • Modèle / numéro de série
    Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Procedure Packs)Frazier Suction HandleProduct Code: UM1912Lot Number: CGCA06-01Foot Pack Health E Care Procedure PackProduct Code: SOPSYML03DLot Numbers: CS1739694, CS1740778, CS1743999, CS1747123 and CS1857459ARTG Number: 137395Lower Extremity Procedure PackProduct Code: SOPMESV06GLot Numbers: CS1741061, CS1742774 and CS1748561ARTG Number 136870
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd