SENSICA UO SYSTEM
Received Mar 6, 2023 · Event occurred Feb 9, 2023
Report 1018233-2023-01434 · MDR key 16493118
Device
Generic name
Sensica Uo System
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
- No Clinical Signs, Symptoms or Conditions
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- No Clinical Signs, Symptoms or Conditions
Narrative
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 SENSICA DEVICE FAILED DUE TO TUBE SENSOR LEFT READS ACTUATED WITH NO TUBE CONNECTED.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE FAILED DUE TO TUBE SENSOR LEFT READS ACTUATED WITH NO TUBE CONNECTED. PER NOTIFICATION RECEIVED ON 07MAR2023, THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS THE FAILURES OCCURRED TO UNITS WHILE IN BD CONTROL THAT HAD NOT BEEN RELEASED FROM THE GDC/INVENTORY WOULD NOT REQUIRE COMPLAINTS. 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.