A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the second complaint for the lot# 8261706 for the same defect or symptom.Previous complaint: (b)(4).There was no documentation of issues for the complaint of batch 8261706 during this production run.
|