H10: manufacturing review: a complaint history review was performed.This is the fourteenth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one powerport mri duo, was returned for evaluation.Visual evaluation, microscopic visual observation, functional testing were performed.The investigation is confirmed for the reported difficult to flush and identified partial blockage issues as significantly more resistance on the right port septum was noted upon infusing.Further the right port septum failed the mandrel test as the black mark was not fully inserted into the lumen.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: 05/2022).H11: section a through f ¿ the information provide 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.
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