As a lot number is unknown for this incident, a complaint history check could not be completed.Quantity of customer samples: according to jfrl report: the protector fitted properly the vial.The expansion chamber could expand but couldn¿t be shrined.It was difficult to see the needle though the rubber stopper.Expansion chamber does not work.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 of the film or between the protector and 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.According to jfrl report, the expansion chamber worked without any issues after having reconnected the protector using m12.This fact suggests that the protector was not properly attached to the vial and therefore it didn¿t work properly.Note that is difficult to see the needle of the protector as the rubber stopper is too thick.If the thickness of the rubber stopper is not the appropriate, there can be issues related to the normal function of protectors.In this case, this potential impediment was avoided using m12.The fixture makes easier the connection.
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