SYRINGE 10ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

IT WAS REPORTED THAT A CATHETER WITH A DAMAGED, LEAKING WALL WAS DISCOVERED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED TO THE QUALITY TEAM. THE IMAGES SHOW A SYRINGE WITHOUT ITS FLOW WRAP PACKAGING. A CRACK IS VISIBLE NEAR THE MID SECTION OF THE SYRINGE BARREL, WITH SOLUTION LEAKAGE AT THE CRACK SITE. THIS CONDITION COULD OCCUR IF A JAM WERE TO OCCUR DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306595, LOT 5140925. THE REVIEW IDENTIFIED NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE ISSUED. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE ASSEMBLY PROCESS CONFIRMED CORRECT ALIGNMENT OF THE RAILS AND CONVEYORS, AND PRODUCT FLOW WAS SATISFACTORY. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER¿S REPORTED CONDITION IS CONFIRMED.

Description of Event or Problem

A DAMAGED AND LEAKING CATHETER WALL WAS DISCOVERED DURING CATHETER REMOVAL.