SENSICA UO SYSTEM
Received Feb 23, 2023 · Event occurred Jan 31, 2023
Report 1018233-2023-01116 · MDR key 16426501
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE. 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 TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED; ENSURED THE TUBE SENSOR LEFT¿ ENTRY READS ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE SENSICA URINE OUTPUT SYSTEM.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. .
Description of Event or Problem
IT WAS REPORTED THAT THE TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED; ENSURED THE TUBE SENSOR LEFT¿ ENTRY READS ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE SENSICA URINE OUTPUT SYSTEM.