BD SYRINGE 5ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 5101629. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FILL CHINA SP HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT. PRESENTED TO THE HOSPITAL FOR PULMONARY EMPHYSEMA. AT 11:20 AM ON (B)(6), AFTER THE PATIENT COMPLETED INTRAVENOUS INFUSION, THE NURSE DISCOVERED A PINHOLE-SIZED BLACK FOREIGN OBJECT INSIDE THE PRE-FILLED CATHETER FLUSHING DEVICE WHILE SEALING THE CATHETER. THE NURSE IMMEDIATELY REPLACED THE FLUSHING DEVICE TO SEAL THE CATHETER AND REPORTED THE INCIDENT TO THE MEDICAL EQUIPMENT DEPARTMENT. NO OBVIOUS SIGNS OF INJURY.