NIAGARA

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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT REQUIRED CONTINUOUS HEMODIALYSIS TREATMENT. WHILE THE ATTENDING PHYSICIAN WAS PLACING A HEMODIALYSIS TUBING IN THE PATIENT¿S LEFT NECK, THE GUIDEWIRE BECAME STUCK AND DID NOT RETRIEVE SMOOTHLY; HOWEVER, BECAUSE IT WAS CONTAMINATED WITH THE PATIENT¿S BLOOD, IT WAS DISCARDED.