(10/3236) the involved product was returned to intervascular and was inspected by the quality assurance (qa) supervisor for an evaluation of the damage extent.His observations are as follows: " the product arrived in its box but damaged.The external and internal lids were not open.There is a match between the product, the labelling of the box and the patient set.The outer lid does not have any haloes on the surface that would suggest that a liquid may have passed through the packaging box." (4308) the most likely cause of this event is an inappropriate transport of the device.In conclusion, the product does not comply with the specifications due to damaged packaging.Based on the defect present on the product box, it is assumed that this is an isolated event due to a shock during transportation.Corrected data: d10.The product was initially reported as not available for evaluation.It has been changed to available for evaluation.
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