SENSICA URINE OUTPUT SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE SENSICA URINE OUTPUT SYSTEM WAS RESTARTING DURING USE. THERE WAS A DAMAGED LOAD CELL.

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.

Additional Manufacturer Narrative

THIS EVENT WAS A CONFIRMED USE OF DEVICE, NOT ATTRIBUTED DEVICE MALFUNCTION. SUBMITTING THE INVESTIGATION DETAILS AS ADDITIONAL INFORMATION. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IDENTIFIED IS USER-DAMAGE. A REVIEW OF THE RISK DOCUMENT, (B)(4), WAS PERFORMED FOR THIS INVESTIGATION. THE REPORTED EVENT IS ADDRESSED IN STEP #20.08. BASED ON THIS REVIEW THE RISK IS WITHIN THE EXPECTED RANGE. THE LABELING/IFU REVISION ACCOMPANYING THIS SERIAL NUMBER IS NOT RECORDED IN THE DHR. THE LATEST LABELING REVISION WILL BE REVIEWED FOR THIS INVESTIGATION. THE INSTRUCTIONS-FOR-USE UNDER BAW0335274 REV 2 IS 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. PRODUCT LABELING WAS REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE AS THE INSTRUCTIONS FOR USE STATE: "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." A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. CORRECTION: D, E, F, G, H. 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 STATED THAT THE SENSICA URINE OUTPUT SYSTEM WAS RESTARTING DURING USE. THERE WAS A DAMAGED LOAD CELL. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15APR2025, THEY CONFIRMED THEY FOUND A DIFFERENT UNIT FOR THE PATIENT USE. DEVICE HAD ALREADY BEEN SENT IN FOR REPAIR.