NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM DL (PRE-CURVED) (SHORT-TERM)

Description of Event or Problem

IT WAS REPORTED THAT WHEN USING THE CATHETER, THE GUIDE WIRE WAS BENT AND COULD NOT BE WITHDRAWN FROM THE PUNCTURE NEEDLE AND COULD NOT BE USED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.