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 were provided and reviewed.Approximately six months and twenty-eight days post port placement, infected vascular access port was removed.The subcutaneous pocket was opened on the right chest and the port was removed from the pocket including the catheter.The tract and port site skin were closed.Around six days later, placement of port was performed after the bacteremia was cleared.After new port placement the port was accessed and easily pulled back blood and flushed without difficulty.The patient tolerated the procedure well and was transferred.Therefore, the investigation is inconclusive for the reported bacteremia as no objective evidence has been provided to confirm any alleged deficiency with the port.Furthermore, 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 (expiry date: 03/2024).H11: section a through f - the information provided by bd represents all of 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.
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