Results: one used sample and one unused sample were received for evaluation by our quality engineer team.Upon examination, the used unit was partially retracted.Through testing, both units were successfully disengaged with the cannula staying locked by the v-clip as intended.A luer-lok syringe was attached and flushed through the unit, all connections were secure and no leakage was observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defects.Conclusion: the root cause of the defect was not determined during the investigation as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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