Events

Imager II Angiographic Catheters 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2016-12-23
  • 사례 출판 날짜
    2016-12-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161223c.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: boston scientific imager ii angiographic catheters medical device manufacturer, boston scientific, has issued two medical device safety alerts (a product advisory and a medical device removal) concerning its imager ii angiographic catheters. the details of the affected device are as follows:- product advisory: material number (upn): multiple lot/batch number: multiple expiration date: 01 april 2018 to 31 july 2018 medical device removal: material number (upn): m001314141 (5-pack outer package upn); m001314140 (single unit, inner package upn) lot/batch number: 00112758 expiration date: may 11, 2018 the manufacturer is initiating a product advisory of a subset of imager ii angiographic catheters and a medical device removal of a single lot (00112758) of imager ii angiographic catheters. following a field report, the manufacturer has determined that some units within a single lot were missing the bottom pouch seal. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. the manufacturer has confirmed that only one batch was missing a bottom seal, as a precautionary measure, the manufacturer is notifying all customers of this issue that received batches processed through this alternate label reprint process. affected users of the captioned upn (m001314141 and m001314140) and lot (00112758) should immediately discontinue use of such product and segregate it for product removal. if other affected users have identified any inventory missing a bottom pouch seal, the same action should be taken. the compromised seal is completely missing and is obvious to the user. the device can be readily exchanged resulting in an insignificant prolongation in procedure. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2016.

Device

Imager II Angiographic Catheters
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheters
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH