Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Investigation summary: two sample units were returned for evaluation by our quality engineer team.Upon visual inspection of the samples, defects could not be observed.Upon functionality testing of the samples, the expansion chambers were found to properly function.As a lot number was unknown for this incident, a production history review could not be completed.Regular inspections and tests are performed during the manufacturing process to ensure product is within specifications.If the protector is used more than once, liquid may accumulate within the filter causing an oversaturation of the hydrophobic filter.If oversaturation occurs, pressure prevents proper air release to the expansion chamber.The same pressure may result if liquid accumulates within the internal face of the vial rubber stopper.
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