BD 10mL Syringe Slip Tip with BD PrecisionGlide Needle 21G 1 1/2 TW 의 안전성 경고

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

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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
    2015-04-15
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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
    Press release
  • 원인
    Recall of syringe slip tip (with photo) the department of health (dh) today (april 15) drew public attention to the recall of a syringe product, bd 10ml syringe slip tip with bd precisionglide needle 21g 1 1/2 tw (0.8mm x 38mm) (catalog(ref) number : 302145 and lot number 4044007), initiated by the manufacturer, becton, dickinson and company (bd). the dh received a safety alert issued by the bd today that the company was conducting a voluntary recall of the above product since a small number of syringes from the affected lot may have a void in the syringe roof. this defect could result in leakage of fluid from the syringe and in some cases the fluid could be expelled or squirt out of the void during injection. "according to the bd, the affected lot was manufactured from may to october, 2014 and 12,000 affected products have been distributed to hospital authority, dh, elderly homes, private doctors and community pharmacies in hong kong," a dh spokesperson explained. the bd was notifying the relevant customers. so far, the dh has not received any adverse incident reports related to the products. the dh will closely monitor the recall. in case members of the public have the products in their possession, they can contact bd on its hotline (2575 8668) for enquiries and assistance. the spokesperson also reminded the public that anyone who is in doubt or feeling unwell after having used the product should consult healthcare professionals. the dh has informed public and private hospitals and relevant medical associations about the issue. ends.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Recall of syringe slip tip (with photo)
  • Manufacturer
    BD

Manufacturer

BD