BIOSENTRY®

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. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. THE COMPLAINT COULD NOT BE CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

CUSTOMER REPORTS THE GEL PLUG DID NOT DEPLOY. THE PRODUCT WAS THROWN AWAY AND A NEW ONE WAS OPENED. NO PATIENT HARM. NO ADDITIONAL DETAILS PROVIDED.