Investigation results: a gap in the solder at the working end can be found.Furthermore damages at the male box lock.Vigilance investigator carried out the pictorial documentation visually and microscopically.A gap at the tip of the needle holder can be found.According to the quality standard, the solder must be even and completely filled.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in pc notification.If the review shows any conspicuities, the report will be updated and actions will be initiated.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and root cause: the solder is not according to the specification valid at the time of production.Due to the investigation results the root cause is most probably manufacturing related.The current failure rate is within the risk analysis and therefore acceptable.Corrective action/ preventiv action: at the moment it looks like an error in production/ qa.It must be checked whether the solder was according to the specifications at the time of production.Q-coordinator of production plant will be informed.It must be checked by the responsible q-coordinator and appropriate measures must be taken.
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