EMBOSPHERE

Additional Manufacturer Narrative

THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER IN RELATION WITH THIS REPORTED EVENT. THE PHOTO CONFIRMS THE REPORTED EVENT. THE VIAL WAS PROBABLY BROKEN DURING TRANSPORT. A BROKEN VIAL CANNOT BE PACKED BY OUR PRODUCTION TEAM BECAUSE A VISUAL CHECK IS CARRIED OUT ON ALL UNITS OF THE PRODUCT TO VERIFY THE INTEGRITY OF EACH UNIT BEFORE PACKAGING IN BOX. THE ACTUAL DEVICE WAS NOT RETURNED, THEREFORE, THE CAUSE CANNOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS.

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING PREP, THAT THE GLASS BOTTLE WAS BROKEN AND UNUSABLE, SO I SWITCHED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.