BD SYRINGE 10ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

IT WAS REPORTED FLUID LEAKAGE OCCURRED. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS AN INVERTED SYRINGE WITHOUT ITS PACKAGING FLOW WRAP. THE PLUNGER ROD APPEARS TO HAVE BEEN DEPRESSED, AND DROPLETS OF SOLUTION ARE VISIBLE. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 306595, LOT 5052295. THE ASSESSMENT DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE, THE REPORTED SYMPTOM HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF A PHYSICAL SAMPLE, IT WAS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE 10 ML SALINE FILL CHINA SP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2025, DURING THE CATHETER SEALING PROCEDURE USING A PRE-FILLED CATHETER FLUSHING DEVICE FOLLOWING INTRAVENOUS THERAPY FOR A PATIENT WITH INTESTINAL NEOPLASM, FLUID LEAKAGE OCCURRED. THE SEALING SOLUTION WAS PROMPTLY REPLACED AND THE CATHETER SUCCESSFULLY RESEALED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND CAUSED NO HARM TO THE PATIENT.