Neither a lot history review nor a dhr review could be performed as the lot number was not provided.One mri power port isp, one cath-lock, and one 8fr groshong catheter were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed, blood residue was noted inside the catheter but was still able to perform as expected during infusion and aspiration.The investigation is inconclusive as the clinical conditions could not be recreated in a laboratory setting, it is possible the blood residue that was dislodged during infusion was clogging the lumen or the valve when it was still placed inside the patient.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.
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This report summarizes one malfunction.A review of the reported information indicated that model 9808560 port & catheter allegedly experienced backflow.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.
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