Device history record review shows no non-conformances associated with the manufacture lot of needles.Review also shows that sample needles from this lot were fatigue tested showing with 95% confidence that 99.9% of the lot would pass a minimum of 24 cycles.Date product received: the product was not returned for evaluation.Device identification: 3910-900-091/h.Visual inspection: where the product was not returned a visual inspection was not performed.Functional inspection: where the product was not returned a functional inspection was not performed.This is a known failure mode addressed in the risk management file for this product, and does not exceed expected occurrence rates.Occurrence rates are monitored for trends.Service history review: there has been no service on this device.Manufacturing date: 12-21-2015.Root cause(s): where the device was not returned and the description of the complaint does not contain enough information, a root cause could not be determined.Manufacturer error: there is nothing in the description of the complaint and there was nothing found in the review of the device history record that would indicate this is a result of a manufacturing error.Country of event: usa.
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