Sample has not been returned for evaluation because the hospital scrapted it.Without sample is not possible to investigate on the root causes.Review of the production document (device history record), doesn't show any deviation of the process and qc inspection doesn't highlight problems on the valve or assembling phase.The lot has never been complained, even if all the units have been distributed on the market.Working by hypothesis, we can consider that the defect was caused by an incorrect assembling of the valve due to a mistake of the operator.The investigation is still in progress; in case of any further new information obtained, a supplemental report will be issued.
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