EPILOR SYRINGE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 BECTON DICKINSON CANADA INC. 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
    100551
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-09-06
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Bd has received several reports indicating that the plunger of the 7 ml bd epilor plastic bd luer-lok loss of resistance syringe (lor) may stall or stick when travelling within the syringe. this may prevent the user from detecting a loss of resistance upon entering the epidural space. if this occurs the user may continue to advance the syringe and needle through the epidural space and the dura into the spinal canal/intrathecal space resulting in a spinal anesthesia instead of an epidural anesthesia. there have been no reports of harm to patients. date the event was first identified: 06/19/2013. bd has received complaints from customers indicating that product has exhibited higher than normal resistance in the 7ml epilor syringe. there have been a total of 7 complaints for related events in the last 3 fiscal years.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 405198 (Lot serial: >10 contact manufacturer); Model Catalog: 405291 (Lot serial: >10 contact manufacturer); Model Catalog: 406078 (Lot serial: >10 contact manufacturer)
  • 제품 설명
    7 mL BD Epilor plastic BD Luer-Lok LOR Syringe (Bulk non-sterile & sterile single use)
  • Manufacturer

Manufacturer