On 3/16/16 integra investigation closed.Date of manufacture: 2ea.08/2014 & 2ea: 12/2014.Method: failure analysis, device history evaluation.Results: failure analysis - four syringes returned in used condition, not showing any unusual markings.The returned syringes showing wear, staining within the harpoon.To test: the syringes were loaded with a new carpule and a new needle attached.During the analysis of the instruments, it was noticed that two out of four did not engage with the harpoon.The remaining two, the stopper got stuck not releasing as intended, causing the carpule to get stuck and when taken out spilled the lidocaine.What was noticed was that the spear was slightly damaged on one of the syringes.Without knowing the differences to the hardness of the rubber or the tolerances and how the spear was inserted the cause is undetermined.The complaint report is confirmed.Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report/nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there is no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.
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