POSIFLUSH

Additional Manufacturer Narrative

(B)(4) FOLLOW UP FOR DEVICE EVALUATION THE SYRINGE WAS REPORTED TO BE FILLED WITH AIR. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT FLOW WRAP PACKAGING WAS RECEIVED FOR EVALUATION BY THE QUALITY TEAM. A CONNECTOR AND A BLUE CAP WERE PRESENT AT THE SYRINGE BARREL LUER IN PLACE OF THE ORIGINAL WHITE CAP. NO SALINE WAS PRESENT, HOWEVER, DROPLETS OF A CLEAR SOLUTION WERE OBSERVED, POSSIBLY RESIDUAL FROM THE DECONTAMINATION PROCESS. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THE SAMPLE. AN EMPTY SYRINGE CONDITION MAY OCCUR AS A RESULT OF A JAM AT THE SOLUTION FILLING STATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306546, LOT 5218281. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING MANUFACTURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. VERIFICATION OF THE FILLING STATION CONFIRMED THAT SETTINGS WERE CORRECT, AND PRODUCT FLOW WAS ACCEPTABLE. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

WENT TO FLUSH IV WITH PREFILLED 10ML POSIFLUSH AND DREW BLOOD RETURN INTO SYRINGE, REALIZED THE SYRINGE WAS FILLED WITH AIR, NO SALINE. NO AIR WAS INJECTED INTO THE IV, NO IMPACT TO PT. SYRINGE WAS DISCONNECTED FROM IV SITE AND PLACED ASIDE. NEW FLUSH WAS CONNECTED AND USED WITHOUT INCIDENT.