SENSICA URINE OUTPUT SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - 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 CUSTOMER EMAILED THAT THE SENSICA URINE OUTPUT DEVICE KEPT REBOOTING DURING USE.

Additional Manufacturer Narrative

THIS EVENT WAS CONFIRMED USE RELATED, NOT ATTRIBUTED TO A DEVICE MALFUNCTION. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED EVENT WAS CONFIRMED TO BE USE RELATED. THE ROOT CAUSE OF THE REPORTED ISSUE IS THAT THE LOAD CELL WAS DAMAGED BY THE USER. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE REBOOTING IS ATTRIBUTED TO A DAMAGED LOAD CELL, WHICH IS USE RELATED. REPLACED LOAD CELL ASSEMBLY. A DAMAGED PEM NUT WAS FOUND ON THE FRONT INTERFACE HOUSING. REPLACED FRONT INTERFACE HOUSING. APPLIED FOAM TO OPTICAL SENSOR AND UPDATED LOAD CELL GROUND CABLE TO CURRENT REVISION. DEVICE PASSED APPLICABLE TESTING AFTER REPAIR. THE INSTRUCTIONS-FOR-USE WERE REVIEWED AND FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. PER THE IFU: 5.3.1 ATTACH RING TO ATTACH THE BD SENSICA RING TO THE STAND, ORIENT THE RING WITH THE HANGER UPWARDS AND USE A CLOCKWISE MOTION TO TWIST AND LOCK THE RING ONTO THE RING INTERFACE. NOTE: IN ORDER TO AVOID DAMAGING COMPONENTS, DO NOT APPLY EXCESSIVE FORCE OR TORQUE THE RING ONTO THE SYSTEM¿S RING INTERFACE WHEN CONNECTING THE DEVICE. DO NOT TURN THE RING COUNTERCLOCKWISE WHEN ATTACHING IT. NOTE: DO NOT PUSH DOWN ON LOAD CELL CONSOLE OR TUG/HANG ON RING AS THIS CAN DAMAGE EQUIPMENT. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE MANUFACTURING RELATED. A DHR REVIEW WAS NOT NECESSARY SINCE BASED ON THE INFORMATION RECEIVED AND THE RESULTS OF THE INVESTIGATION, THERE IS NO INDICATION THAT THE EVENT IS MANUFACTURING RELATED. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTIONS: B, D, E, F, H UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS A THROUGH F - 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 CUSTOMER EMAILED THAT THE SENSICA URINE OUTPUT DEVICE KEPT REBOOTING DURING USE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 27JUN2025, ANOTHER SENSICA WAS USED FOR TREATMENT. PER SAMPLE EVALUATION RESULTS RECEIVED VIA TASK ON 07JUL2025, IT WAS REPORTED THAT THE DAMAGED PEM NUT WAS FOUND.