Lot number 1802114 for product (b)(4) was provided for evaluation by our quality engineer.A device history record review did not reveal any documented quality issues during the production of lot number 1802114 that could have contributed to the reported incident.As a sample was not provided, a thorough sample investigation could not be competed.Two retained samples of the same lot number were obtained for further investigation.Through visual inspection of the retained samples, no defects were observed.The retained samples were functionally tested and the expansion chambers were observed to expand properly.If the protector product is used more than once, liquid may accumulate and oversaturate the hydrophobic filter.If oversaturation occurs, the resulting pressure can prevent proper release of air to the expansion chamber.The same pressure prevention may occur if liquid accumulates within the internal face of the vial rubber stopper.Based on the investigation results, a definite cause for the reported incident could not be determined.Complaints received for the reported defect and device will continue to be monitored for emerging trends.This is the first complaint of expansion chamber does not work for lot 1802114, product (b)(4).No actions indicated as the defect was not confirmed.
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