SENSICA UO SYSTEM
Received Feb 22, 2023 · Event occurred Jan 31, 2023
Report 1018233-2023-01070 · MDR key 16416891
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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS THERE WAS NO ALLEGATION AGAINST THE PRODUCT. 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 A 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 TO THE SENSICA DEVICE. A MESSAGE HAD BEEN RECEIVED COULD BE SEEN ON RSS PORTAL UNDER DEVICE STATUS. THE DEVICE FAILED TUBE SENSOR LEFT AND ONCE ACTUATED AND TUBE WAS REMOVED, IT STATED ACTUATED AND NEVER RETURNS TO OPEN.
Description of Event or Problem
IT WAS REPORTED THAT A 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 TO THE SENSICA DEVICE. A MESSAGE HAD BEEN RECEIVED COULD BE SEEN ON RSS PORTAL UNDER DEVICE STATUS. THE DEVICE FAILED TUBE SENSOR LEFT AND ONCE ACTUATED AND TUBE WAS REMOVED, IT STATED ACTUATED AND NEVER RETURNS TO OPEN.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.