Events

Vital Port Vascular Access System Tip: Petite Titanium; Mini Titanium; Petite Dual; Standard M.R.I, Petite M.R.I; Standard Titanium Power Injectable Port 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Cook Incorporated 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
    2017-11-29
  • 사례 출판 날짜
    2018-01-31
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2018/01/31/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-vital-port-vascular-access-system-tip-petite-titanium-mini-titanium-petite-dual-standard-m-r-i-petite-m-r-i-standard-titanium-power/
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • 데이터 추가 비고
  • 원인
    During non-coring needle testing, it was observed that the non-coring needle provided with the cook vital-port vascular access system (vital-port) could cut or tear off the core or tear off a small portion of the material from the vital-port "of the septum, when the non-coring needle is inserted into the" vital-port ". this non-coring needle is used for the initial implantation of vital-port. potential adverse events that may occur may occur from silicone nuclei or particles that can embolize into the patient's bloodstream. additionally, drugs can leak out of the port, resulting in inadequate drug delivery and potential injury to surrounding tissues.Ports that have been successfully implanted are not covered by this withdrawal.

Device

Vital Port Vascular Access System Tip: Petite Titanium; Mini Titanium; Petite Dual; Standard M.R....

Manufacturer

Cook Incorporated