RHV

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS UNKNOWN WHAT MAY HAVE CAUSED THE REPORTED LOOSE OR INTERMITTENT CONNECTION AND UNSTABLE. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. 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 THE THREE-WAY STOPCOCK DID NOT FIT SECURELY INTO THE ROTATING HEMOSTATIC VALVE (RHV), AND THE CONNECTION PART REMAINED LOOSE, ROTATING FREELY. ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL; THEREFORE, A NEW Y-CONNECTOR WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.