NIAGARA

Additional Manufacturer Narrative

THE INITIAL COMPLAINT APPEARED TO BE A REPORTABLE OCCURRENCE. UPON RECEIVING ADDITIONAL INFORMATION ABOUT THE EVENT, IT WAS DETERMINED THAT A REPORTABLE EVENT HAD NOT OCCURRED.

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 DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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.

Description of Event or Problem

IT WAS REPORTED, A DIALYSIS CATHETER WAS PLACED FOR BLOOD PURIFICATION THERAPY. THE PROCEDURE WAS PERFORMED UNDER ULTRASOUND GUIDANCE. FIRST ATTEMPT (SUBCLAVIAN VEIN): THE NEEDLE LEAKED FLUID WITHOUT NEGATIVE PRESSURE, RESULTING IN UNSUCCESSFUL PLACEMENT; THE NEEDLE WAS WITHDRAWN. SECOND ATTEMPT: UNDER ULTRASOUND GUIDANCE, THE NEEDLE WAS ADVANCED TO THE TARGET SITE AND A GUIDEWIRE WAS PLACED (INTERNAL JUGULAR VEIN). THE PROCEDURE TOOK APPROXIMATELY 15 MINUTES LONGER THAN ROUTINE.