RHV

Additional Manufacturer Narrative

A VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. AS THE REPORTED LOOSE OR INTERMITTENT CONNECTION COULD NOT BE CONFIRMED DURING THE RETURN ANALYSIS. IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED, NOT FULLY CONNECTED OR TIGHTENED WHILE ATTEMPTING TO CONNECT OR THE PORT OF THE DEVICE BEING CONNECTED WAS COMPROMISED, RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, THIS COULD NOT BE CONFIRMED. ADDITIONALLY, IT IS POSSIBLE THAT THE CONTAMINATION INSIDE THE BODY WAS INADVERTENTLY INTRODUCED INTO THE HEMO VALVE ROTATING (RHV) DURING DEVICE PREPARATION OR THROUGH INTERACTION WITH OTHER DEVICES; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE STOPCOCK WAS ATTACHED TO THE ROTATING HEMOSTATIC VALVE (RHV) BUT THE STOPCOCK BECOMES LOOSE AFTER TIGHTENING. THIS OCCURRED WITH 9 TOTAL RHVS AND ATTEMPTED DIFFERENT COMBINATIONS OF STOPCOCKS AND RHVS BUT ALL HAD THE SAME ISSUE. THE TENTH RHV WITH A NEW STOPCOCK WAS SUCCESSFULLY USED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WERE MULTIPLE BLACK PIECES OF UNKNOWN MATERIAL INSIDE THE BODY OF ONE OF THE RHV'S. NO ADDITIONAL INFORMATION WAS PROVIDED.