Events

BioSensors_BioMatrix NeoFlex Drug Eluting Coronary Stent System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Biosensors Europe SA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    19857
  • 사례 시작날짜
    2016-03-07
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Recalling Organisation: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • 원인
    Manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, manufacturer concluded that the compromised balloon performance was caused by certain characteristics in the manufacturing process. biosensors positively identified production lots manufactured between october to december 2015 that could have been similarly affected., the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient's state of health during pci., patients who have already been implanted with an affected device are not impacted by this field safety corrective action. no field complaint or patient injury has been reported associated with the compromised balloon performance.
  • 조치
    Product to be returned to supplier

Device

BioSensors_BioMatrix NeoFlex Drug Eluting Coronary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Model: BMXP-3511, BMXP-3518, BMXP-4018, BMXP-4024, Affected: Batches: W15100548 W15100236 W15100237 W15100238 W15110086 W15120234
  • Manufacturer
    Biosensors Europe SA

Manufacturer

Biosensors Europe SA