H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records provided and reviewed.Approximately four months and twenty-nine days post port placement, port removal was indicated due to bacteremia.Successful removal of previously placed right internal jugular central venous infusion port.There were no overt signs of port infection.Port catheter tip cut and sent for culture.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence has been provided to confirm any alleged deficiency to the port.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 04/2023).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: device not returned.
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