SENSICA URINE OUTPUT SYSTEM
Received Jan 9, 2025 · Event occurred Jan 6, 2025
Report 1018233-2025-00050 · MDR key 21114499
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IDENTIFIED IS AN OLD REVISION OF THE LOAD CELL GROUND CABLE. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE NEEDS NEW REVISION OF LOAD CELL GROUND CABLE. REPLACED LOAD CELL GROUND CABLE. GENERAL MAINTENANCE PERFORMED. REPLACED OPTICAL SENSOR. UPDATE SOFTWARE. TESTING WAS PERFORMED IN ACCORDANCE WITH (B)(4). 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. CORRECTIONS: 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 SENSICA URINE OUTPUT SYSTEM WAS SENT TO BIOMED AS NOT BEING ACCURATE. DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF ACCURACY LOAD CELL.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM WAS SENT TO BIOMED AS NOT BEING ACCURATE. DEVICE WOULD BE SENT TO THE DEPOT FOR ASSESSMENT OF ACCURACY 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.