RHV

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3: ESTIMATED DATE THE ADDITIONAL DEVICES REFERENCED IN B5 ARE CAPTURED UNDER SEPARATE MEDWATCH NUMBERS.

Description of Event or Problem

IT WAS REPORTED IN A GENERAL COMMENT THAT THE RHV WOULD NOT ALLOW A SYRINGE TO BE SCREWED ON DURING THE PROCEDURE. THE DEVICE WOULD POP OFF OR JUST SPIN AROUND. AN OILY SUBSTANCE WAS NOTED ON THE GLOVES OF THE PROVIDERS AS WELL. THE ISSUE OCCURRED WITH 3 OTHER DEVICES. A NEW RHV WAS ULTIMATELY ABLE TO BE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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. STERILE/UNUSED UNITS PASSED THE VISUAL AND FUNCTIONAL TESTING ACCORDING TO SPECIFICATIONS, WITH NO ANOMALIES NOTED. 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 CONTAMINATION / DECONTAMINATION PROBLEM (FOREIGN SUBSTANCE). 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.