BD SYRINGE 10ML SALINE FILL CHINA SP

Description of Event or Problem

IT WAS REPORTED THAT THE BD SYRINGE 10ML SALINE FILL CHINA SP CAP FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO PERFORMING PICC MAINTENANCE ON PATIENT, THE NURSE DISCOVERED THAT THE CANNULA CAP HAD SEPARATED FROM THE CANNULA SHAFT AFTER OPENING THE CATHETER FLUSH DEVICE PACKAGING. THE NURSE REPLACED THE PRODUCT WITH ANOTHER FROM THE SAME BATCH AND SPECIFICATION TO CONTINUE THE PATIENT'S TREATMENT, CAUSING NO HARM TO THE PATIENT. NO RECURRENCE OF THIS ISSUE WAS OBSERVED DURING SUBSEQUENT TREATMENTS.

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.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 303537, LOT 5070123. 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 DEFECT OF CAP FALLS OFF 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 INFORMAITON PROVIDED.