SENSICA URINE OUTPUT SYSTEM

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 THE TUBE SENSOR WAS NOT ABLE TO DETECT THE PRESENCE OF THE CATHETER TUBING IN AN SENSICA DEVICE.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE SENSICA URINE OUTPUT SYSTEM WAS EVALUATED UPON RECEIPT. DURING THE EVALUATION IT WAS FOUND THAT THE ALIGNMENT OF THE OPTICAL SENSOR WITH THE APPLIED FOAM AFFECTED THE REPORTED EVENT. OPTICAL SENSOR FOAM WAS REPLACED. TESTING WAS PERFORMED. DEVICE PASSED ALL APPLICABLE TESTING. THE INSTRUCTIONS-FOR-USE ARE 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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSU CORRECTION: D,H 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 THE TUBE SENSOR WAS NOT ABLE TO DETECT THE PRESENCE OF THE CATHETER TUBING IN AN SENSICA DEVICE.