Events

Alerte De Sécurité sur Check-Flo Blue Valve Devices

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cook Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-02-09
  • Date de publication de l'événement
    2017-02-09
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170209.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: cook medical check-flo blue valve devices medical device manufacturer, cook medical, has issued a medical device safety alert concerning its check-flo blue valve devices, details product brand name (catalogue identifier[prefix/suffix]) as below: check-flo hemostasis assembly ( cfm-200) flexor radial access set ( kcfn-4.0(5.0, 6.0, 7.0)- / -ra-(s)-hc) triforce peripheral crossing set ( kcxs-5.0- / -rb-0/0-hc, kcxs-5.0- / -rb-0/dav-hc, kcxs-5.0- / -rb-mpb/0-hc, kcxs-5.0- / -rb-mpb/dav-hc) check-flo performer introducer set ( rcf-4.0(5.0, 6.0, 7.0, 8.0)- / -bv check-flo performer introducer ( rcfw-4.0(5.0, 6.0, 7.0, 8.0)- / -bv micropuncture check-flo performer introducer set ( rcfn-4.0(5.0, 6.0, 7.0)- / -mpis-nt-bv check-flo introducer hausdorf-lock atrial ( rcfw-7.0(8.0)-38-75-rb-hla-091100-bv the manufacturer identified an increase in reports of blood loss associated with devices using a specific hemostatic valve design (referred to as the “blue” valve or polyisoprene valve). in november 2015, products manufactured with the hemostatic blue valve design were either obsoleted or changed to incorporate a different valve design with improved hemostasis. the manufacturer has continued to receive reports of blood loss associated with the earlier generation products containing the “blue” valve and therefore has initiated this action on those devices. according to the manufacturer, potential adverse events that may occur if these devices were used in the arterial system (flexor radial access sets) include delay in procedure and blood loss. if devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. the manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. return the affected products to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 9 february 2017.

Device

Check-Flo Blue Valve Devices
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cook Medical Check-Flo Blue Valve Devices
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical