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目的了解密闭式静脉留置针临床安全性相关信息，指导医疗器械临床安全使用。方法通过分析2003~2015年临床观察报道，了解临床中所观察病例的不良事件的发生率和临床表现。结果2060例患者使用了密闭式静脉留置针，其中有310例（15.05%）患者发生了不良事件；主要临床表现为液体渗漏、静脉炎等11种临床不良事件。结论加强医疗器械的安全性监测，提高临床操作技能，及时发现和处理所发生的不良事件，控制和减少患者安全性事件的发生。“,”Objective To know the clinical safety of the closed vein indwelling needle and guide the clinical safety of medical device. Methods Analysis the safety data, about ADE rate and clinical symptoms by the clinical observation reports from 2003~2015. Results Among 2060 patients, 310 patients (15.05%) had adverse events, the main clinical symptoms were liquid leakage, phlebitis and others. Conclusion Strengthen the safety monitoring of medical devices, improvement the clinical operation skills and detection and treatment of adverse events in time in order to control and reduce the occurrence of patient safety incidents.