Events

Cook Vital-Port 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 Cook Medical Europe 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 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
    Cook medical is launching a voluntary recall process for the above products. during the testing of the needle-less needle, it was found that the needle-less needle provided with the vascular access cook vital-port® (vital-port) cuts or displaces the core or fragment of the material of the vital-port system barrier when inserted into the vital-port system. the needle is used on the initial insert of the vital-port system. withdrawal does not affect vital-port products that have been successfully inserted in patients.   possible side effects that may occur are the side effects of silicone cores or fragments that can embolize into the patient's bloodstream. in addition, medicines can leak out of the port, resulting in inadequate drug delivery and possible damage to surrounding tissues.   so far, no adverse events have been reported due to leakage of the barrier or fragments of silicone pushed into the patient in connection with these products.

Device

Cook Vital-Port
  • 모델명 / 제조번호(시리얼번호)
    Vascular system access to Vital-Port Titanium Power for injection Single-chamber systems IP-7110 IP-S7010 IP-S7110 IP-S9010 IP-S9110 G20254 G26434 G26436 G26438 G26440 All series Vascular system access to Vital-Port Standard, Petite and Mini Titanium and MRI Single-chamber systems IP-5112-N IP-5112-NC Vascular system access to Vital-Port Standard and Petite Titanium Two-chamber systems IP-S1021 IP-S1121 IP-S7029 IP-S7129 IP-S7129-MPIS-NT G26428 G26429 G26502 G26504 G50863 All series IP-5116 IP-5116-N IP-5118-N IP-5118-NC IP-6018 IP-6113 IP-7112 IP-9112 IP-S5016 IP-S5018 IP-S5116 IP-S5116-MPIS-NT IP-S5116-N IP-S5116W IP-S5116W-MPIS-NT IP-S5118 IP-S5118-N IP-S6010 IP-S6012 IP-S6013 IP-S6018 IP-S6110 IP-S6112 IP-S6113 IP-S6113-MPIS-NT IP-S6118 G46543 G26539 G26468 G46544 G46545 G26540 G26510 G26424 G19803 G19769 G26469 G26507 G26470 G50864 G46546 G26472 G26489 G26509 G46547 G26430 G26458 G26431 G26511 G26432 G26449 G26433 G50860 G26513 All series  page 2 of 3    Form: F14-00A (R10, CR16-0422) © AUTHOR DOCUMENT IP-S6118-MPIS-NT IP-S7012 IP-S7112 IP-S9012 IP-S9112 G50861 G26435 G26437 G26439 G26441
  • Manufacturer
    Cook Medical Europe

Manufacturer

Cook Medical Europe