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 mri implantable port with an attached catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is inconclusive for the reported suction and air aspiration issues, as the exact circumstances at the time of the reported event are unknown.Furthermore, pressure was felt when guidewire was inserted into the port stem, exposing thrombus on the distal tip of the guidewire.Port body was flushed within with water and water was observed exiting the port stem.A definitive root cause could not be determined based upon the provided 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 (expiration date: 02/2024), g3, h6 (method).H11: h6 (result, conclusion).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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