Supplemental report is being filed since the results of investigation are available after the initial mdr was filed.The investigation consisted of a review from cardinal's device history record video image and the special instructions, as well as the pack¿s configuration by the design department.(b)(4) kits were produced in work order #577589.This work order was manufactured on 2/17/2021.The production team inspected every 50th kit and no discrepancies were found.The quality assurance team inspected the pack #1 and no discrepancies were found.No non-conformance was generated for this work order.Capas, events, nc¿s and complaints are reviewed regularly through various means including, but not limited to capa review boards, management reviews, complaint trending reviews, and monthly metrics.Complaint and capa history would be included in any distributed product field action review when making decisions of field actions.Capa effectiveness checks would also be verifying for recurring issues post corrective action.Complaint history reviews are performed for each complaint for the catalog and/or component in question.The assembly process system was reviewed, the electronic device history record, and the video image.This work order (b)(4) was manufactured in 2/17/2021.Order quantity (b)(4) kits.Quality inspected 4 kit.There is no non-conformance for this work order.There are no special instructions on the affected work order.There is no documented batch number in the device history record (dhr).The production team¿s previous work order was reviewed to ensure proper line clearance between orders; and showed nothing out of the ordinary that could have contributed to the contamination reported of loose debris.The production team failed to detect any contamination of this sort during the assembly process.There was no picture provided for evaluation.Please see capa-jrz-02174.The production team was notified of the complaint for heightened awareness and reminded of the importance for inspecting for contamination and to follow regular cleaning protocol.We will continue to monitor the trend of this type of incident.
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