Events

BMC RF Cannula 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baylis Medical Company 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
    64250
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0879-2013
  • 사례 시작날짜
    2012-10-04
  • 사례 출판 날짜
    2013-02-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115670
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Probe, radiofrequency lesion - Product Code GXI
  • 원인
    A report of an event was received indicating that upon opening a box containing 10 sterile cannula by a nurse, the pouch package of 5 of the 10 individually packaged cannula had not been sealed along one edge. thus the pouch was open and the device could fall out of the pouch and on to the floor when retrieved from the shelf box. the cannulas were not used on any patients, as the unsealed packages.
  • 조치
    A recall was initiated on 10/04/2012 and a letter was sent out to the distributor with a Fax-back Acknowledgment Form. The letter described the issue and provided recommendations and a contact number.

Device

BMC RF Cannula
  • 모델명 / 제조번호(시리얼번호)
    Device Model #: 1 PMF 16-145-10CS. Lot number: PFFB 190811.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International distribution to the country of Australia.
  • 제품 설명
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed into shipping cartons (tertiary packaging). The BMC RF Cannula is intended for use in radiofrequency heat lesion procedures for relief of pain.
  • Manufacturer
    Baylis Medical Company Inc.

Manufacturer

Baylis Medical Company Inc.
  • 제조사 주소
    Baylis Medical Company Inc., 5160 Explorer Drive #33, Mississauga Canada Ontario
  • 제조사 모회사 (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA