SENSICA UO SYSTEM
Received May 24, 2022 · Event occurred May 4, 2022
Report 1018233-2022-04081 · MDR key 14492568
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Component Missing
- Component Missing
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 WAS MISSING COVER AND ONE OF THE PINS TO HOLD THE RING ON THE SENSICA DEVICE.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A CASCADING FAILURE OF AN EVENT PREVIOUSLY REPORTED. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS MISSING COVER AND ONE OF THE PINS TO HOLD THE RING ON THE SENSICA DEVICE.