POSIFLUSH

Additional Manufacturer Narrative

(B)(4). FOLLOW UP: IT WAS REPORTED THAT A FOREIGN BODY WAS PRESENT INSIDE THE SYRINGE, APPEARING TO BE A BROKEN FRAGMENT FROM ANOTHER SYRINGE. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, FIVE PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGES SHOW A SYRINGE WITHOUT FLOW WRAP PACKAGING CONTAINING APPROXIMATELY 8ML OF SOLUTION, WITHIN WHICH A PIECE OF PLASTIC IS VISIBLE. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306547, LOT 5275833. THE REVIEW IDENTIFIED NO QUALITY ISSUES DETECTED DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE RECORDED. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH APPLICABLE SPECIFICATION REQUIREMENTS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER REPORTED SYMPTOM IS CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

NO ADVERSE EVENT OR INJURY, RN NOTICED BEFORE ADMINISTRATION TO THE PATIENT.

Description of Event or Problem

THERE IS A FOREIGN BODY INSIDE THE SYRINGE. LOOKS TO BE A BROKEN PIECE FROM ANOTHER SYRINGE.

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.