MEDEX EXTENSION FILTER SETS

Additional Manufacturer Narrative

DEVICE EVALUATION: NO PRODUCT OR PHOTOS WERE RETURNED; THEREFORE, NO DEVICE ANALYSIS COULD BE COMPLETED. WITHOUT THE RETURN OF THE SAMPLES USED A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE CARRIED OUT, AND A PROBABLE CAUSE CANNOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT THE LIPID FILTER WAS LEAKING WHILE CONNECTED TO PICC LINE. THIS WAS NOT A LABORATORY DEVICE OR LABORATORY TEST. ADVERSE PATIENT EFFECTS ARE UNKNOWN.