As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event 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 9808560 implantable port allegedly experienced device-device incompatibility.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and sex were not provided.
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