BIOSENTRY

Description of Event or Problem

THE CUSTOMER REPORTED THAT UNITS "WERE NOT SEALED CORRECTLY LEAVING THEM UNSTERILE." THIS WAS FOUND BEFORE PATIENT USE AND THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT TO MEET FDA CRITERIA FOR REPORTING. THIS 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 IN THIS REPORT. THE DEVICE WAS RECEIVED FROM THE CUSTOMER. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE POUCH WAS UNSEALED, THEREFORE THE PRODUCT WAS UNSTERILE. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. 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. THE COMPLAINT HAS BEEN CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE CONFIRMED.