BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Becton Dickinson Pty 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
    RC-2013-RN-00922-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-06
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    Bd has received complaints relating to difficulty in moving the plunger rod or the plunger rod sticking. this has the potential to prevent the anaesthetist from correctly detecting the loss of resistance upon entering the epidural space.
  • 조치
    Prior to using each syringe, it is recommended that anaesthetists ensure that there is no difficulty in moving the plunger rod and that the plunger rod does not stick. Any LOR Syringe that shows inappropriate resistance should be discarded; the procedure can then be continued by using another LOR Syringe that does not show resistance.

Device

  • 모델명 / 제조번호(시리얼번호)
    BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)Reference Number: 405291Lot Numbers: 0039440, 0154661, 0174905, 0252565, 1012200, 1124755, 1213029, 1312116, 1320204, 2286395, 2303141, 2334338, 2334339, 8277525, 8357843, 9093622 and 9149990ARTG Number: 120174
  • Manufacturer

Manufacturer