RHV

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE 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 LEVEL PRODUCT QUALITY ISSUE. IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED AND/OR NOT FULLY CONNECTED/TIGHTENED WHILE ATTEMPTING TO CONNECT AND/OR THE PORT OF THE DEVICE BEING CONNECTED WAS COMPROMISED RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, THIS CANNOT BE CONFIRMED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION 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 DURING PREPARATION OF THE ROTATING HEMOSTATIC VALVE (RHV), THE DEVICE DID NOT THREAD ONTO THE MANIFOLD AND TIGHTEN SECURELY. ADDITIONALLY, THERE WAS LEAKING AT THE POINT OF CONNECTION. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.