Investigation summary: dhr: n/a - no lot available quantity of customer samples: 2 (injector +protector).Conclusion(s): 1 protector + 1 injector were tested by jfrl.According to the report the defect was not confirmed.According to the report: visual inspection shows no defects in both injector and connector samples.N35 could connect to protector properly.Function test is acceptable (expansion chamber inflates properly and it is possible to draw drug).Inspections and tests in manufacturing area for protectors: protector housing were manufactured by nolato supplier.Currently, they are molded in bd san agustin plant.Visual inspections and critical dimensions for protector housing parts are performed according to ph-300 current version.During assembly process, the operator performs the following inspections and tests according to ph-302 current version: it is verified that expansion film of the bladder is centered in the protector housing, correctly sealed and free of holes or damages.Visual inspection of the filter is performed to verify that is centered in the protector cavity, welded in a right position and free of holes between the filter and filter cover.Overpressure test is performed to verify that the expansion film of the bladder can resist certain pressure.-film breakage test: the expansion film of the bladder must break at minimum pressure (0,8 bar).It is verify if the break is produced in the sealing area or at the film.Functionality test is performed to ensure properly work of the protector.Hydrophobic filter leakage is performed to verify that no leaks are present in the filter.To perform the two last test the protector needs to be connected to an injector.Investigation conclusion: according to jfrl report, the claimed defect was not confirmed.The root cause cannot be established.
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