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 the reported difficult to insert, unable to infuse and aspirate issue.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 1708070 implanted port allegedly experienced difficult to insert, unable to infuse and aspirate issue.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender were not provided.
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