BEARING NSPVA

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. 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. RETENTION SAMPLES FROM THE SAME BATCH ARE COMPLIANT. THE POWDER HAS A COMPLIANT APPEARANCE AND IS NOT FOUND IN THE CAP. MANY CUSTOMERS RECEIVED THIS BATCH, WHICH CONTAINS (B)(4) UNITS, AND ONLY 2 INDIAN CUSTOMERS SENT A COMPLAINT. IN SOME CASES, THE POWDER MAY REMAIN IN THE AREA OF THE CAP OR ON THE INNER WALL OF THE VIAL. IN SUCH CASES, GENTLY TAPPING THE VIAL WILL ALLOW THE POWDER TO SETTLE AT THE BOTTOM OF THE VIAL. BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS NOT POSSIBLE TO FULLY PERFORM THE INVESTIGATION OF THIS COMPLAINT AND PROVIDE CAUSE OF THE REPORTED ISSUE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING PREPARATION OF BEARING NSPVA, THE OPERATOR FOUND THAT THE VIAL WAS EMPTY. THERE WAS NO PATIENT INJURY.