H6: investigation summary: seven used samples were provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed in all received samples.The product was disassembled for further inspection, in six of the samples it was confirmed there was no damage in the plunger rod or other components that could have caused a leak.One syringe was observed to have damage on the barrel, a dent was noted near the 50ml marking.A device history review was performed for the reported lot 1912211, an incident was detected related to the imbalance of the ball bearings in the assembly station which resulted in barrels jamming within the machine.Once identified, our mechanical team repaired this issue and defective units were scrapped.It is likely this impacted unit was not properly detected.There was no non-conformances identified during manufacturing that could have contributed to the reported defect of medication remaining in the syringe.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including tightness testing to verify the stopper seal and silicone content and force testing to verify proper plunger movement.Five retained samples of lot 1912211 were used to conduct these tests, in all cases the product functioned as intended and was verified to be within required specifications.Based on our investigation and sample evaluation, we cannot identify a defective root cause at this time.In relation to the one damaged syringe, the leak was likely a result of the dent observed on the syringe barrel which occurred during manufacturing.H3 other text : see h10.
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