DIALYSIS CATHETER

Description of Event or Problem

A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE BD DIALYSIS CATHETER. POST PROCEDURE, IT WAS NOTED THAT THE CUFF HAD EXTRUDED AND WAS EXPOSED. THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LOOSENING OF IMPLANT AND EXPULSION ISSUES AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED SECTION A THROUGH F: THE INFORMATION PROVIDE 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.