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 implantable port attached to catheter was returned for evaluation.Gross visual, functional, tactile and microscopic visual evaluations were performed.No break characteristics were noted throughout the catheter.The investigation is confirmed for the reported septum detachment issues and the identified fracture and material separation issues, as the septum was received detached, but a circular piece of the port body was returned broken away from the rest of the port body.The surface of the circular piece of the port body was noted to be rough and granular with residue stains throughout.Three areas throughout the circular piece of port body border were noted to be broken off from their original location.Thrombus was noted within the distal end of the catheter attached.However, the investigation is inconclusive for the reported clot around the device issue as the exact circumstances at the time of the reported event are unknown and clinical conditions cannot be replicated to confirm these failures.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: 10/2015).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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