Events

Becton Dickinson Plastipak 50ml Luer Lok Syringe 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Becton Dickinson & Company Ltd 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
    16067
  • 사례 시작날짜
    2014-04-08
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • 원인
    Bd has received complaints concerning an increase in the occurrence of occlusion alarms with the bd plastipak™ 50ml luer lok syringes. the root cause has been determined to be increased plunger rod forces primarily due to the interaction between the syringe barrel and the rubber stopper. initially bd recommended a change in the settings of the syringe pumps. however, investigation after continued complaints were received has revealed that it was not technically feasible to change the pump settings on some types of syringe pumps. bd has redesigned the syringe plunger to reduce the plunger forces required.
  • 조치
    Manufacturer to issue advice regarding use

Device

Becton Dickinson Plastipak 50ml Luer Lok Syringe

Manufacturer

Becton Dickinson & Company Ltd