SENSICA URINE OUTPUT SYSTEM
Received Jun 6, 2022 · Event occurred May 16, 2022
Report 1018233-2022-04386 · MDR key 14600986
Device
Generic name
Sensica Uo Monitor
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Material Fragmentation
- Material Fragmentation
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. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA RING WOULD NOT ATTACH CORRECTLY AND FRONT COVER FOR RING ATTACHMENT HAD COME OFF. THE DEVICE WAS SENT TO BIOMED. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 17MAY2022, THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE HAD NOT BEEN REPAIRED AND BIOMED WOULD DECIDE IF THE DEVICE BE SENT IN FOR REPAIR.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA RING WOULD NOT ATTACH CORRECTLY AND FRONT COVER FOR RING ATTACHMENT HAD COME OFF. THE DEVICE WAS SENT TO BIOMED. AS PER THE FOLLOW UP INFORMATION RECEIVED ON 17MAY2022, THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE HAD NOT BEEN REPAIRED AND BIOMED WOULD DECIDE IF THE DEVICE BE SENT IN FOR REPAIR.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. A ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE FOR THE REPORTED ISSUE COULD BE DEFORMATION OF THE CONNECTING ELEMENTS. HOWEVER, THIS COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS AN AUTOMATED SYSTEM FOR CONTINUOUS MONITORING OF URINE OUTPUT (UO) AND CORE BLADDER TEMPERATURE WHEN CONNECTED TO A TEMPERATURE-SENSING FOLEY CATHETER. TARGET POPULATION: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS INTENDED FOR BEDSIDE MONITORING OF URINE OUTPUT FOR ANY PATIENT WITH AN INDWELLING, UROLOGICAL CATHETER, DRAINAGE TUBING AND COLLECTION BAG, TYPICALLY IN CRITICAL CARE SETTINGS OR WHERE CLOSE MONITORING OF URINE OUTPUT IS DESIRED. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS ALSO INTENDED FOR MONITORING CORE BLADDER TEMPERATURE WHEN USED WITH THE BD SENSICA¿ TEMPERATURE MONITOR MODULE AND A BD 400 SERIES TEMPERATURE-SENSING FOLEY CATHETER OR EQUIVALENT. 1.3 CONTRAINDICATIONS THERE ARE NO KNOWN CONTRAINDICATIONS FOR USE WITH PATIENTS WHO HAVE INDWELLING, UROLOGICAL CATHETERS IN PLACE." H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED