Events

Alerta De Seguridad para Check-Flo Blue Valve Devices

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Cook Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-02-09
  • Fecha de publicación del evento
    2017-02-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170209.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Cook Medical Check-Flo Blue Valve Devices
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical