SENSICA URINE OUTPUT SYSTEM
Received Mar 7, 2023 · Event occurred Feb 14, 2023
Report 1018233-2023-01478 · MDR key 16495865
Device
Generic name
Sensica Uo Monitor
Manufacturer
C.r. Bard, Inc. (covington) -1018233Catalog 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
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA URINE OUTPUT SYSTEM HAD SIGNIFICANT SHIPPING DAMAGE. THE POLES WERE BENT ALONG WITH THE BASE ASSEMBLY. THE TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED. ENSURED THE TUBE SENSOR LEFT¿ ENTRY READ ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE DEVICE. PER REVIEW OF WO ON 20FEB2023, 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.
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 URINE OUTPUT SYSTEM HAD SIGNIFICANT SHIPPING DAMAGE. THE POLES WERE BENT ALONG WITH THE BASE ASSEMBLY. THE TUBE SENSOR LEFT ENTRY READS ¿OPEN¿ WHEN BAG TUBE WAS NOT ATTACHED. ENSURED THE TUBE SENSOR LEFT¿ ENTRY READS ¿ACTUATED¿ AFTER BAG TUBE WAS CONNECTED ON THE DEVICE. PER REVIEW OF WO ON 20FEB2023, THERE WAS NO PATIENT INVOLVEMENT.