SENSICA URINE OUTPUT SYSTEM
Received Aug 30, 2024 · Event occurred Aug 12, 2024
Report 1018233-2024-05300 · MDR key 20106601
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Defective Component
- Device Sensing Problem
- Defective Component
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE IQVIA TEAM CAME OUT TO PERFORM UPDATES SENSICA URINE OUTPUT SYSTEM FAILED THE OPTICAL SENSOR TEST. OPTICAL SENSOR FAILURE.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 WHEN THE IQVIA TEAM CAME OUT TO PERFORM UPDATES SENSICA URINE OUTPUT SYSTEM FAILED THE OPTICAL SENSOR TEST. OPTICAL SENSOR FAILURE.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE THE INVESTIGATION DETAILS. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE RISK DOCUMENT WAS PERFORMED FOR THE INVESTIGATION. THE REPORTED EVENT IS ADDRESSED, AND BASED ON THIS REVIEW, THE RISK ACCEPTABLE; THEREFORE, THIS EVENT IS NOT REPORTABLE. SAMPLE WAS NOT RECEIVED. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE WAS ISOLATED TO A FAULTY OPTICAL SENSOR. IT WAS NOTED THAT WHEN THE IQVIA TEAM CAME OUT TO PERFORM UPDATES SENSICA URINE OUTPUT SYSTEM FAILED THE OPTICAL SENSOR TEST. OPTICAL SENSOR FAILURE. THE INSTRUCTIONS-FOR-USE WERE REVIEWED AND FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.