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.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
데이터 추가 비고
원인
During testing of the non-coring needle, it was identified that the non-coring needle provided with the cook vital-port® vascular access system (vital-port) may cut or dislodge a core or sliver of material from the vital-port septum when the non-coring needle is inserted into the vital-port. this needle is used on the initial implant of the vital-port.