The Analysis and Suggestions on Adverse Events of Disposable Intravenous Catheters Based on Real World Data
Objective To analyze the adverse events of disposable intravenous catheters and propose improvement suggestions,based on real world data.Methods With the collection of adverse event reports of disposable intravenous catheters received by Linyi Pharmacovigilance Center from January 1,2023 to April 30,2024,after excluding misreports,false reports,repeated reports and invalid reports,a total of 351 adverse event reports were included.Adverse event reports were analyzed in terms of reporting institutions,product situation,patient situation,adverse event injury manifestations,catheters failure types,causes of adverse events and types of injury,and disposal situations.Results 351 adverse event reports were all reported by medical institutions,of which 284 cases were reported by secondary and above medical institutions(accounting for 80.91%);A total of 14 manufacturers and 28 registration certificate numbers were involved,including 27 domestic registration certificate numbers(accounting for 96.43%);With a wide age distribution(2 months to 97 years old),patients involved in adverse events were mainly concentrated in the ages of 0-10 and 61-80;The main manifestations of adverse event injuries were secondary punctures,bleeding,and allergies caused by various reasons;The main manifestations of catheter failure were leakage,bending,and breakage;The main cause of the malfunction was a problem with the product itself;Among the 351 cases reported,168 cases were serious injuries(accounting for 47.86%)and 183 cases were other injuries(accounting for 52.14%).Among the 168 reports with serious injuries,151 cases were treated by replacing the catheter for secondary puncture(accounting for 89.88%).Conclusion It is suggested that nurses improve the level of puncture and standardize the operation process.Medical institutions should strengthen nursing training and medical device management to prevent unqualified products from entering clinical practice;Production enterprises should optimize their production processes to ensure product quality and safety;Regulatory authorities should strengthen full chain supervision to ensure the safety of patients using equipment.
Disposable intravenous catheterReal world dataAdverse eventsSafe use of equipment
万方数据
维普
