SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. PER FOLLOW UP INFORMATION, BD IS GOING TO REPLACE THE BROKEN UNITS FREE OF CHARGE. THE LABELING AND IFU REVISION ACCOMPANYING THIS SERIAL NUMBER IS NOT RECORDED IN THE DHR. 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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. CORRECTIONS: 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 RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATING THEIR SENSICA DEVICE, THE PLASTIC CAP COVER THAT LOCATED BEHIND THE RING OF IT SENSICA WAS PULLED OFF AND DISLODGED. WHEN THE SENSICA DRAINAGE BAG THAT WAS HOOKED ON TO THE FRONT OF THE DEVICE WAS TOO TALL AND URINE BACKFLOWING. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 30JAN2026, BD IS GOING TO REPLACE THE BROKEN UNITS FREE OF CHARGE. THEY ARE WAITING FOR CS TO ADVISE ON NEXT STEPS. 4 BOXES WILL BE SHIPPED FOR THEIR RETURN, FIX THEM, AND SEND THEM BACK. PROBABLY A 3 WEEK PROCESS. THEY HAVE 3 MORE UNITS THAT WERE EXPERIENCING SOFTWARE ISSUES AND THEY ARE TRYING REALLY HARD TO WORK ON THEN THIS WEEK. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 02FEB2026, PROVIDED LIST OF THE BROKEN SENSICA'S, SN (B)(6) RING CAP MISSING. SN (B)(6) RING CAP MISSING. SN (B)(6) RING CAP MISSING AND CAP ATTACHMENT BROKEN. SN (B)(6) MONITOR BROKEN OFF AND HANGING FROM BY THE WIRES. SN (B)(6) ONE OF THE FOUR CONTACTS ON THE RING INTERFACE WERE DAMAGED. THE OTHER 2 HAD SOFTWARE ISSUES. THEY WERE TESTED BY BIOMED AND IT WAS DETERMINED THEY WORK PROPERLY. BIOMED PUT THEM BACK IN SERVICE ON THE NURSING UNIT. ASKING WHETHER THEY CONTACT WHO WILL COORDINATE THE REPAIR OF THE 5 UNITS THAT WERE BROKEN.

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 RCC RECEIVED A COMPLAINT VIA PHONE. CUSTOMER STATING THEIR SENSICA DEVICE, THE PLASTIC CAP COVER THAT LOCATED BEHIND THE RING OF IT SENSICA WAS PULLED OFF/DISLODGED . # 2 WHEN THE SENSICA DRAINAGE BAG THAT WAS HOOKED ON TO THE FRONT OF THE DEVICE WAS TOO TALL/URINE BACKFLOWING.