HEMASHIELD PLATINUM

Additional Manufacturer Narrative

((B)(4)) 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. ((B)(4)) 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 IN ORDER TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT AND TAKE APPROPRIATE CORRECTIVE ACTION IF NECESSARY.

Description of Event or Problem

IT WAS REPORTED BY THE HOSPITAL TWO CASES WERE THE DEVICES WERE FOUND WITH NO LABEL FOR DOCUMENTATION AND NO DIRECTION FOR USE IN THE PACKAGING. THE DEVICES WERE USED WITHOUT ANY CONSEQUENCE FOR PATIENTS. THE SECOND CASE IS SUBMITTED UNDER MANUFACTURER REPORT NUMBER 1640201-2018-00003.