SENSICA UO SYSTEM
Received Sep 9, 2025 · Event occurred Sep 3, 2025
Report 1018233-2025-07722 · MDR key 23008810
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002E
Lot number
NA
Product problems
- Nonstandard Device
- Calibration Problem
- Nonstandard Device
- Calibration Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 PER WO EVALUATION, THE SENSICA URINE OUTPUT DEVICE BODY CONTROL MODULE (BCM) WAS UNABLE TO PASS THE SCREEN CALIBRATION PORTION OF SOFTWARE UPGRADE. NEEDS NEW BODY CONTROL MODULE (BCM).
Description of Event or Problem
IT WAS REPORTED THAT THE PER WO EVALUATION, THE SENSICA URINE OUTPUT DEVICE BODY CONTROL MODULE (BCM) WAS UNABLE TO PASS THE SCREEN CALIBRATION PORTION OF SOFTWARE UPGRADE. NEEDS NEW BODY CONTROL MODULE (BCM).
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED BODY CONTROL MODULE. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICES BCM IS UNABLE TO PASS THE SCREEN CALIBRATION PORTION OF SOFTWARE UPGRADE. NEEDS NEW BCM. DEVICE BCM WAS REPLACED. UPGRADED TO CURRENT SOFTWARE REVISION. TESTING WAS PERFORMED. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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. CORRECTION: D, F, 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.