UNKNOWN TEMPORARY PACING ELECTRODE

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE ACCESS IN RELATION TO SEMI-FLOATING TEMPORARY PACING ELECTRODE.

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE ELECTRODE WAS NOT SUCCESSFULLY PLACED BECAUSE ACCESS IN RELATION TO SEMI-FLOATING TEMPORARY PACING ELECTRODE.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.