Events

Alerta De Seguridad O Notificaciones De Seguridad para Unomedical high concentration oxygen masks (specific lots)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por ConvaTec.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2017/019
  • Fecha
    2017-07-10
  • Fecha de publicación del evento
    2017-07-10
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/unomedical-high-concentration-oxygen-masks-specific-lots-risk-of-hypoxia-as-the-tubing-can-disconnect-from-the-oxygen-mask
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by convatec – due to a manufacturing fault, the tubing may disconnect from the oxygen mask, prior to use or during use, causing a disruption in the supply of oxygen to patients (mda/2017/019).
  • Acción
    Identify and stop using affected devices (see below). Quarantine all affected devices in stock. Contact ConvaTec to acknowledge receipt of the Field Safety Notice (dated 10 May 2017) even if you don’t have affected devices left in stock For any product replacements required, see Field Safety Notice for further details

Device

Unomedical high concentration oxygen masks (specific lots)
  • Modelo / Serial
  • Descripción del producto
    The following model (REF number) and LOT numbers are affected:Product Code / REF No. SAP Code Description LOT No’s. NHS Supply Chain Codes (NPC) FDD 104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631   106MM 1702436 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7’) Oxygen Tubing 100733, 104106, 104798, 100721, 109824 763 108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 102766, 102785, 102726, 102352, 105451, 109186   108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100281, 100709, 100729, 101923, 103180, 103265, 103691, 103714, 104104, 105987, 110558 2747 3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 102727   3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 100720, 101141   3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1 m (7’) Oxygen Tubing 104906, 105181 766 9108MM 1267152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7’) Oxygen Tubing 100232, 100694, 100918, 101639, 101897, 103067, 104846, 104848, 105453
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Dirección del fabricante
    Rebecca Evans ConvaTec LimitedTelephone: 01244 284896
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    MHRA