No failure product but pictures of the failure product were sent in for examination.The manufacturing documentation and the manufacturing specifications of the batch concerned were examined and did not allow any negative conclusions to be drawn.The facts of the case were examined.Result: the defect could be traced.The luer connection of the cannula hub has separated from the rest of the hub.This could be confirmed by examination of the pictures sent in by the customer.When examining a retention sample of the article from the corresponding batch, no deviations could be found.The luer connection could not be separated from the lor syringe even by strong force after connecting the syringe.The cause of the error cannot be determined beyond doubt without examining the product.We are not aware of any other complaints with this defect pattern at present.It is possibly a single product error.Based on clinical evaluation report and risk management file this file is considered as closed unless further information becomes available.
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