Department, israel on (b)(6) 2022.Reporter stated that the adverse reactions occurred at hematooncology pediatric unit at (b)(6), israel with heparin lock flush solution, usp, 500 units/5 ml ( 100 units/ml) syringes, manufactured by medefil.During last year of use they had approximately 10-15 patients (with different diagnosis) experiencing nausea and sometimes vomiting after using heparin lock flush syringes.She stated that this happened after the nurse had withdrawn the blood samples in the morning and then they flushed the line with heparin lock flush to prevent the catheter from clotting.Patients age range was 5 - 20 years.Nausea and vomiting is a known hypersesitivity adverse reaction with heparin lock flush (also mentioned in the package insert - copy enclosed).In addition, reporter stated that they had sold more than 1.97 million syringes between 2019-2021 to more than 30 medical centers.No adverse reaction reports has been received for nausea and vomiting.They have received only two complaints about difficulty in operating the syringe due to improper use.
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