Events

Hypodermic Syringes Plastic BD - See Annex I 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company 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
  • 사례 ID
    1698
  • 날짜
    2015-10-09
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    The company informs that the health risk related to the storage of drugs in hypodermic syringes (use in disagreement with the purpose of the product) is the decrease in potency and, consequently, the potential need for an additional dosage. Medications identified so far as potentially impacted are used for pain control and / or as a component of a controlled anesthetic procedure. They are always used by healthcare professionals in a monitored environment with immediate reaction capacity for intervention, ranging from additional dosing of medications to life support systems if needed. Also, frequent monitoring and scheduling of medication is within the standard medical practices for these drugs, in which the dosage for each patient is individualized, based on the response of the medication to the medication.
  • 원인
    Recently the bd in the united states has received reports of decreased potency of some drugs when stored in sterile hypodermic syringes of bd plastic. that is, when the syringes are not used right after filling. based on the reports received, it was identified that the cause of the decrease in potency is related to the interaction of some drugs with the cork used in sterile hypodermic syringes of plastic bd when they are stored. this situation encompasses all 1ml, 3ml, 5ml, 10ml, 20ml bd syringes, bd plastipak insulin syringe 1 ml and anesthesia trays where the syringes in question are present. bd ultra-fine syringes for insulin, bd posiflush saline and heparin, pharmaceutical validated syringes for pharmaceutical containers (hypak and sterifill) and 60 ml bd syringes are not impacted. to date, decreased potency of drugs stored in the bd syringes has been reported for: fentanyl, rocuronium, neostigmine, morphine, midazolam, methadone, atropine, hydromorphone, cisatracurium, and remifentanil. the bd confirms the information that sterile hypodermic bd plastic syringes have been developed, manufactured and registered for aspiration and injection soon after filling. such syringes should not be used for drug storage as they are not designed and manufactured for this purpose. we emphasize that to date, no adverse events related to this problem have been reported.
  • 조치
    Becton Dickinson Industries Surgical Ltda confirms the information that sterile hypodermic BD plastic syringes have been developed, manufactured and registered for aspiration and injection soon after filling. Such syringes should not be used for the storage of medicines, as they were not designed and manufactured for this purpose. We remind you that if you are using sterile hypodermic BD plastic syringes according to the purpose of use (aspiration followed by injection) and not for storage prior to administration, you can continue to use any of the products. The BD is available to clarify any specific technical doubts and provide the necessary assistance through its telephone 0800 055 5654 or by e-mail

Device

Hypodermic Syringes Plastic BD - See Annex I

Manufacturer

BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA.; Becton Dickinson and Company