Events

Alerta De Seguridad para Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters

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

¿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
    2016-09-21
  • Fecha de publicación del evento
    2016-09-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160921.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: vascular solutions twin-pass, twin-pass rx and twin-pass .023" catheters medical device manufacturer, vascular solutions, inc., has issued a medical device safety alert concerning its twin-pass, twin-pass rx and twin-pass .023" catheters. [model numbers: 5200, 5210, 5230; lot numbers: 575653, 577278, 577279, 577761, 577762, 578419, 578996, 578997, 579472, 5797s7, 580186, 580612, 580613, 581252, 582138, 582579, 582580, 583021, 583785, 584155, 584156, 584463, 584812, 585176, 585784, 585785, 586310, 586399, 587030, 587407, 587772, 588499, 588542, 588962, 589457, 589884, 590169, 590350, 590561, 590717, 590739, 591037, 591261, 591262, 591521, 591739, 592078, 592525, 592920, 593076, 593678, 593695, 593696, 593717, 593985, 594678, 595191, 595412, 595413, 596317, 596930, 596936, 597006, 597034, 597035, 597036, 597037]. the manufacturer has become aware of a potential problem with their twin-pass (5200), twin-pass rx (5210) and twin-pass .023” (5230) dual access catheters. investigation concluded that there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. it is possible that the excess material may separate from the catheter during a procedure, which poses a potential risk of an embolism to the patient. according to the manufacturer, there have been no reports of adverse patient events related to this issue. the manufacturer is voluntarily recalling and replacing all affected units of twin-pass, twin-pass rx and twin-pass .023”. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 september 2016.

Device

Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medical Device Safety Alert: Vascular Solutions Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
  • Manufacturer
    Vascular Solutions

Manufacturer

Vascular Solutions