SENSICA UO SYSTEM
Received Oct 14, 2022 · Event occurred Oct 4, 2022
Report 1018233-2022-07847 · MDR key 15606992
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
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 ENGINEERING UNIT HAVE NOTED THAT THE SENSICA DEVICE WAS NOT DETECTING THE TUBE AT START-UP OR ON UTILITY APP. THEY BELIEVE THE TWO TUBE ISSUE DEVICES NEEDED THE OPTICAL SENSOR REPAIR (SERIAL# (B)(4)) AND (SERIAL# (B)(4)).
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND THAT THERE WAS NO ALLEGATION AGAINST PRODUCT. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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 ENGINEERING UNIT HAVE NOTED THAT THE SENSICA DEVICE WAS NOT DETECTING THE TUBE AT START-UP OR ON UTILITY APP. THEY BELIEVE THE TWO TUBE ISSUE DEVICES NEEDED THE OPTICAL SENSOR REPAIR (SERIAL# (B)(6).