Events

BD Plastipak Syringes / BD Oral Syringes 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Becton Dickinson GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2015-09-30
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    We have received reports from us customers of decreased potency when drugs are compounded or repackaged and stored in bd plastipak syringes. because of the potential public health impact when the syringes are used in this way, we are issuing this communication to assist in identifying affected syringes. .

Device

BD Plastipak Syringes / BD Oral Syringes
  • 모델명 / 제조번호(시리얼번호)
    Dates (MM/YYYY) Lot Details Luer-Lok™ syringe 309658 8/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301073 10/2014-06/2015 Refer to bd.com/alerts-notices Oral syringe 305210 305220 305853 03/2014-05/2015 Refer to bd.com/alerts-notices Luer-Lok™ syringe 309649 08/2012-Present Refer to bd.com/alerts-notices Bulk non-sterile syringe 301027 08/2012-07/2015 Refer to bd.com/alerts-notices With BD Eclipse™ needle 305785 03/2012 - Present Refer to bd.com/alerts-notices With BD SafetyGlide™ needle 305907 03/2011 - Present Refer to bd.com/alerts-notices Oral syringe 305855 305218 07/2014-07/2015 Refer to bd.com/alerts-notices 300613 301183 301190 Bulk non sterile Eccentric Tip syringe 300220 07/2013-Present Refer to bd.com/alerts-notices 30mL Luer-Lok™ syringe 302832 01/2013-07/2014 Refer to bd.com/alerts-notices Catheter Tip 300867 06/2013 - Present Refer to bd.com/alerts-notices Bulk non sterile catheter tip 300228 08/2014- Present Refer to bd.com/alerts-notices 5mL 20mL Eccentric Tip syringe 01/2015-Present Refer to bd.com/alerts-notices 50mL 3 ml With BD SafetyGlide™ needle 305904 09/2012 - Present Refer to bd.com/alerts-notices Syringe Size Product Type Catalog No. Produced with Alternate Stopper
  • Manufacturer
    Becton Dickinson GmbH

Manufacturer

Becton Dickinson GmbH