Investigation: the investigation was carried out visually.Without opening the plastic bag, a hair can be found.Furthermore the filters were forwarded to the manufacturer for investigation.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to a manufacturing error.Rational: according to the statement from the r&d department, hairs or other foreign particles are not allowed in the packing.The manufacturer will implement several improvement activities: the process of changing garments, correct wearing of the hairnet, defined areas.A capa will be carried out by the manufacturer.
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