SENSICA UO SYSTEM

Additional Manufacturer Narrative

UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS THE FAILURES OCCURRED TO UNITS WHILE IN BD CONTROL THAT HAD NOT BEEN RELEASED FROM THE GDC/INVENTORY WOULD NOT REQUIRE COMPLAINTS. THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED. ENSURED THE TUBE SENSOR LEFT¿ ENTRY READS ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE SENSICA URINE OUTPUT SYSTEM. DURING THE EXECUTE FILED ACTION PER REQUIREMENTS REPROCESSING PROTOCOL SENSICA TOUCHSCREEN FIRMWARE UPDATE FIELD ACTION, TO ADDRESS DEVICE PERFORMANCE ISSUES RELATED TO PHANTOM TOUCHES THAT MIGHT OCCUR AFTER CLEANING WITH CLEANING OR DISINFECTING WIPES AND TO INACCURATE VOLUME MEASUREMENTS. THE TUBE SENSOR LEFT FAILED AND SHOWED ACTUATED WITH NO TUBE INSTALLED. PER REVIEW OF WO ON 16FEB2023, THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED; ENSURED THE TUBE SENSOR LEFT¿ ENTRY READS ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE SENSICA URINE OUTPUT SYSTEM. PER REVIEW OF WO ON (B)(6) 2023, THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.