Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged infection of vascular access could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.
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It was reported through the results of a clinical trial that post conduit implant inserted surgically, the patient was diagnosed with infection of vascular access with severe intensity, which resulted in hospitalization.The subject was treated with antibiotics and underwent subtotal excision of conduit.The event was definitely related to the study conduit and not related to the study procedure.The current status of the patient is unknown.
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