Unfortunately the sample used during this reported incident was not available for evaluation it was disposed of by the end-user; therefore the failure mode could not be confirmed at this time.The device history record was reviewed for the reported lot number and no issues related to the reported failure mode were found.The product was manufactured, inspected, and released in accordance with carefusion/(b)(4) internal procedures.The needle is not manufactured by carefusion/(b)(4), this is a supplied component.Carefusion/(b)(4) will continue to do incoming inspections to this product per policy.A supplier corrective action request has been initiated to further investigate into this reported failure mode.Carefusion/(b)(4) will continue to work with the supplier to determine a root cause for this customer's report.
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