(b)(6).In this mdr, bd corporate headquarters in (b)(6) has been listed.Teleflex is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Finished device: device history records for finished product part number evaluated.Line clearance, first article, in-process inspection and final qa inspection performed without any quality issues.Product is documented as having met all form, fit and functional requirements at time of shipment.Subcomponent: device history records for subcomponent product part number evaluated.Line clearance, first article, in-process inspection and final qa inspection performed without any quality issues.In-process dimensional and performance records for the subcomponent lots evaluated against requirements.No issues identified.No information from the review of the processes, raw or finished materials , or equipment indicates that the finished product was non - conforming at time of shipment.No root cause can be determined as no samples were received for investigation.No capa is required.
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