SENSICA UO SYSTEM
Received May 4, 2022 · Event occurred Feb 28, 2022
Report 1018233-2022-03178 · MDR key 14275017
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Material Fragmentation
- Material Fragmentation
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
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE BROKEN WIRES ON RING OF THE SENSICA DEVICE. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, THIS EVENT OCCURRED ON (B)(6) 2022, AND NO REPORTED INJURIES OR PATIENT USE DURING REPORTED EVENT. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AS THE INITIAL REPORTER DID NOT PROVIDED THAT INFORMATION.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE BROKEN WIRES ON RING OF THE SENSICA DEVICE. PER FOLLOW UP INFORMATION RECEIVED ON 11APRIL2022, THIS EVENT OCCURRED ON 28FEB2022, AND NO REPORTED INJURIES OR PATIENT USE DURING REPORTED EVENT. PER FOLLOW UP INFORMATION RECEIVED ON 26APR2022, IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AS THE INITIAL REPORTER DID NOT GIVE THAT INFORMATION.