Events

Retiro De Equipo (Recall) de BSN Propax - Surgical procedure kits

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por BSN Medical 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
    21061
  • Fecha de inicio del evento
    2017-01-31
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: BSN Medical Ltd, 621 Rosebank Rd, Avondale, AUCKLAND
  • Causa
    Sterile consumable devices are being delivered with foreign particles found in a number of packets from two batches, appearing to be dust, lint , cardboard. another packet was found today with at least three foreign bodies in that it appear and feel (through the packing only ) to be metal shards/ shavings. two different batches are involved. this problem has the potential to cause injury or infection in patient. if the consumables are used in the manner they are meant to be, in the treatment of wounds following surgery. manufacturer advised medsafe would be informed today (26 jan 2017), 03februiary 2017 source of the metal fragment is the raw material, i.E. the maternity pad. company has then drawn the correlation that this raw material is used in some of bsn's sterilised customised procedure packs (cpps) and therefore are extending the product alert to include the cpps in its scope.
  • Acción
    Manufacturer to issue advice regarding use

Device

BSN Propax - Surgical procedure kits
  • Modelo / Serial
    Model: , Affected: 046, 056, 076, 096, 106 116 066, 086
  • Manufacturer
    BSN Medical Ltd

Manufacturer

BSN Medical Ltd