Events

Retiro De Equipo (Recall) de Leongatha Delivery Pack containing umbilical clamps

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01043-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-09
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01043-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Mölnlycke health care has become aware of situations where the umbilical clamp included in the procedurepak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. if the clamp is used incorrectly i.E. both hooks in the clamp are not engaged, the clamp may reopen. if the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.The ifu will be improved to include further instruction to ensure correct usage of the clamps.
  • Acción
    Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage: - Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks. - Place the (thick) umbilical cord towards the ring end. - Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017.

Device

Leongatha Delivery Pack containing umbilical clamps
  • Modelo / Serial
    Leongatha Delivery Pack containing umbilical clampsProduct number: 97047649-01Umbilical clamps ref.: IFKR21 and 2305123-00All batches are affectedARTG Number: 133562
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd