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 physical device was not returned for evaluation.Five photo were provided for review.The investigation is inconclusive for the reported leak issue as the exact circumstances at the time of reported event was unknown and cannot be confirmed from the provided photo review.Therefore, the investigation is confirmed for the reported septum dislodgement as one of the lumen was protruding the powerport in the provided photo.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.(expiry date: 05/2022).Device not returned.
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