The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-mar-2023.H6: investigation summary: six 3ml syringe samples and nine photos received by our quality team for investigation.Upon visual evaluation of the photos, syringes are displayed, no defects or issues can be observed.Physical samples were evaluated, damaged barrel, and damaged needle shield are 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 defect.Further analysis was performed, verification of luer dimensions were performed for damaged luer, they are outside the specification limits.During review of the process, possible root cause for damaged barrel is due to accumulation of product causing excess weight.Damaged luer and damaged needle shield is associated with resistance in nozzle of needle-barrel assembly process.
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