The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation.Therefore, the investigation is inconclusive for difficult to flush and flushing problem.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model 1708062 implantable port allegedly experienced difficult to flush and flushing problem.This information was received from one source.This malfunction involved a patient with no consequences.Age, weight, and gender were not provided.
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