BD SYRINGE 10ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303537, LOT 5073340. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DETECTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THERE ARE NO SAMPLES AND NO PICTURES, SO THE INVESTIGATION OF THE SAMPLES CANNOT BE CARRIED OUT. VISUAL INSPECTION WAS PERFORMED FOR 180 EA OF RETAIN SAMPLES OF THIS BATCH, NO LEAKAGE WAS DETECTED. BASED ON THE CURRENT INVESTIGATION RESULTS, IT CANNOT BE DETERMINED THAT THE DEFECT REPORTED BY THE CUSTOMER WAS CAUSED BY THE PRODUCTION PROCESS.

Description of Event or Problem

NO ADDITIONAL INFORMATION PROVIDED.

Additional Manufacturer Narrative

D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2025, A PATIENT VISITED OUR HOSPITAL'S OUTPATIENT/EMERGENCY NURSING STATION FOR ¿PICC CATHETER MAINTENANCE.¿ DURING THE PROCEDURE, THE NURSE PRACTITIONER DISCOVERED THAT THE INNER PACKAGING OF AN UNOPENED PRE-FILLED CATHETER FLUSHING DEVICE (10ML) CONTAINED SCATTERED WATER DROPLETS. IT WAS DETERMINED THAT THE SCREW CAP ON THE CONE-SHAPED TIP WAS NOT TIGHTLY SEALED, CAUSING LEAKAGE. THIS COMPROMISED THE STERILE PACKAGING, RESULTING IN VISIBLE CLOUDINESS IN THE SOLUTION. THE PRE-FILLED CATHETER FLUSHING DEVICE WAS SUBSEQUENTLY REPLACED FOR THE PATIENT, WITH NO ADVERSE EFFECTS OBSERVED.