HEMASHIELD PLATINUM

Additional Manufacturer Narrative

A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED TESTS AND PROCEDURES AND NO ANOMALY WAS FOUND. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CASE, A (B)(4) HEMASHIELD PLATINUM WOVEN BOX WAS OPENED. THE BOX WAS INTACT AND WAS PROPERLY LABELED AND HAD THE PLASTIC TRAY INSIDE THE BOX BUT NO GRAFT.

Additional Manufacturer Narrative

THE INVOLVED DEVICE WAS RECEIVED BY INTERVASCULAR AND WAS INSPECTED BY THE QUALITY ASSURANCE SUPERVISOR. THE PRODUCT WAS RETURNED WITH ITS OUTER BLISTER UNSEALED, WITHOUT MOISTURE POUCH, WITHOUT INNER BLISTER AND WITHOUT GRAFT. THE PRODUCT, AS IT WAS RETURNED, DOES NOT CONFORM TO THE SPECIFICATION. CONSIDERING THE CONDITION IN WHICH THE PRODUCT WAS RETURNED (POUCH AND SEALING OPEN), THE CAUSE OF THE REPORTED EVENT CAN NOT BE IDENTIFY. NO CONCLUSION CAN BE DRAWN. THE INVESTIGATION PERFORMED WOULD TEND TO INDICATE THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. HOWEVER, A NON-CONFORMANCE REPORT HAS BEEN INITIATED TO FURTHER INVESTIGATE THE EVENT AND TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY.