Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Results: a sample is not available for evaluation.A review of the device history record revealed that the device was manufactured between 3/19/2016 - 3/23/2016 and there were no irregularities during the manufacture of the reported lot # 6144291.A manufacturing review revealed no abnormalities during incoming inspection, in process inspection, and outgoing inspection.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Additionally, although unconfirmed, our quality engineer states that possible causes may be related to deformation of the cannula, the tilt v-clip getting stuck in the tip shield, and bending of the cannula.
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