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: one powerport clearvue slim implantable port attached to catheter.Was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.An in-house syringe was attached to a safety infusion set and the non-coring needle was inserted into the port septum.The port body was patent to both infusion and aspiration without any issue.The investigation is inconclusive for the reported difficult to flush and suction issues, as the exact circumstances at the time of the reported event cannot be verified, and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023).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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