Events

Bard BrachySource Seed Implants 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Brachytherapy, 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
    79972
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1702-2018
  • 사례 시작날짜
    2018-04-10
  • 사례 출판 날짜
    2018-04-27
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164063
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • 원인
    Bard medical division is recalling the bard¿ brachysource¿ iodine125 radioactive seeds in mick¿ applicators and bard¿ brachysource¿ iodine125 radioactive seeds loose in vial with sterile spacers. because the incorrect dosage level radioactive seeds were mixed up and sent to two hospitals. one hospital ordered brachysource¿ iodine125 0.36 mci radioactive seeds but instead received brachysource¿ iodine125 0.28 mci radioactive seeds and vice versa for the other hospital affected.
  • 조치
    The notification to the customer was completed by Bard Medical Customer Service via a telephone call to alert them of the incorrect product shipped on April 10, 2018. Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial with Sterile Spacers. The incorrect dosage level of radioactive seeds was sent to 2 hospitals. One hospital ordered 0.36 mCi radioactive seeds but instead received 0.28 mCi radioactive seeds intended for the other hospital. For further questions, please call (770) 385-0562.

Device

Bard BrachySource Seed Implants
  • 모델명 / 제조번호(시리얼번호)
    Product Code:1251CSR, BrachySource¿ Seed Implants in Re-Usable Mick¿ Applicators (60 seeds at 0.28mCi) with Lot BBCP0079  Product Code: 1251CSRA, BrachySource¿ Seed Implants in Shielded Mick¿ Applicators (10 seeds at 0.28mCi) with Lot BBCQ0026  Product Code: PS1251LS, Loose BrachySource¿ Seed Implants (with Lot BBCQ0050) Spacers (with Lot 23498276) 100 Seeds at 0.36 mCi.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the states of : California and Georgia
  • 제품 설명
    BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and 35.5 keV gamma. The titanium wall of the BrachySource¿ Seed Implants absorbs the electrons.
  • Manufacturer
    Bard Brachytherapy, Inc.

Manufacturer

Bard Brachytherapy, Inc.
  • 제조사 주소
    Bard Brachytherapy, Inc., 295 E Lies Rd, Carol Stream IL 60188-9421
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA