POSIFLUSH

Additional Manufacturer Narrative

(B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THAT THE SYRINGE WAS CLOUDY. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT FLOW WRAP PACKAGING WAS RECEIVED AND EVALUATED BY THE QUALITY TEAM. THE SAMPLE FEATURED A GREEN CONNECTOR IN PLACE OF THE SPECIFIED WHITE TIP CAP, WHICH DID NOT PROVIDE AN ADEQUATE SEAL AND RESULTED IN LEAKAGE OF THE SALINE SOLUTION. A VISUAL INSPECTION WAS PERFORMED, THE SYRINGE CONTAINED 6.5 ML OF SOLUTION, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. APPEARANCE AND CLARITY TESTING WAS CONDUCTED IN ACCORDANCE WITH APPLICABLE STANDARDS, AND THE UNIT MET THE ACCEPTANCE CRITERIA. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306547, LOT 5218232. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING MANUFACTURE OR INSPECTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER¿S REPORTED SYMPTOM COULD NOT BE 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

IT IS REPORTED CLOUDY SALINE SYRINGE. DESCRIBE THE EVENT OR PROBLEM: THE NURSE GRABBED A SALINE FLUSH OUT OF THE STORAGE CONTAINER AND NOTED THAT THE SYRINGE WAS CLOUDY. THE LOT NUMBER WAS WRITTEN DOWN. LOOKED THROUGH ALL THE OTHER SALINE SYRINGES PRESENT AND NO OTHER CLOUDINESS WAS NOTED.