Investigation report received by manufacturer.No anomaly in product was found, according to the complaint description and returned product inspection.This is not an issue caused by product defect.As there is no evidence of product malfunction.A review of the device history record of the involved product, confirmed there was not any anomaly in product manufacture and inspection process.
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The patient had some "oozing" after 2mls of air was removed from the balloon, the rn inserted the 2mls back into the balloon and noted the "oozing" stopped.She went back to check on the patient, and the balloon had went completely flat.She re-inflated with 6mls, ensured the patient was ok and when she went back to check again, the balloon was flat again."" the vascband was removed and a new vascband was placed.
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