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 14.5 fr d/l hemosplit 19 cm str hemodialysis catheter with surecuff was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for catheter dislodgement due to tissue in-growth problem, as no obvious abnormalities in the returned sample were discovered during visual observation.The detailed examination showed the cuff to be stable and not moving on the catheter under manual manipulation.Blood and fluid residue could be observed on the sample and on the catheter cuff.The conditions at the time of the reported event could not be reproduced in the lab.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date:12/2019).
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