Based on the available information, this event is deemed to be a reportable malfunction.Based on information provided, there is no patient harm in this case.After review of the returned unused product sample, a discrepancy was found.Visual examination found that the product inside the pouch was not corresponding with the product printed on the pouch label.This warrants further action and a non-conformance, has been opened.This complaint will remain open until completion of non-conformance.No additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.
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