SENSICA URINE OUTPUT SYSTEM
Received Apr 22, 2025 · Event occurred Apr 18, 2025
Report 1018233-2025-02917 · MDR key 21886772
Device
Generic name
Sensica Urine Output System
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Component Misassembled
- Device Sensing Problem
- Component Misassembled
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 PROBLEM STATED WAS THE SENSICA URINE OUTPUT SYSTEM DID NOT READ THE TUBING IN THE SENSOR ON THE SIDE. THE FRONT 3 PINS LOOK GOOD ON THIS UNIT IN THE FRONT WHERE THE O RING CONNECTS.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS THAT THE OPTICAL SENSOR IS NOT SITUATED CORRECTLY IN THE HOUSING CAUSING IT TO READ INCORRECTLY. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE EXPERIENCING OPTICAL SENSOR ISSUES IS ATTRIBUTED TO THE DEVICE NOT HAVING THE FOAM APPLIED TO THE SENSOR. TUBING NOT DETECTED CODE 18 SEEN. APPLIED FOAM TO OPTICAL SENSOR. UPDATED LOAD CELL GROUND CABLE TO NEW REVISION. DEVICE PASSED ALL FINAL FUNCTIONAL VERIFICATION REQUIREMENTS. TESTING WAS PERFORMED. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. A DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE PROBLEM STATED WAS THE SENSICA URINE OUTPUT SYSTEM DID NOT READ THE TUBING IN THE SENSOR ON THE SIDE. THE FRONT 3 PINS LOOK GOOD ON THIS UNIT IN THE FRONT WHERE THE O RING CONNECTS.