SYRINGE 3ML SALINE FILL CHINA SP

Description of Event or Problem

IT IS REPORTED, SEALING CAP HAD FALLEN OFF, MAKING IT UNUSABLE. NO PATIENT HARM.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP. THE CUSTOMER REPORTED THAT THE OUTER PACKAGE WAS INTACT, HOWEVER, THE SEALING CAP HAD DETACHED. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED TO THE QUALITY TEAM. THE IMAGE DEPICTS A PREFILLED SYRINGE WITHIN AN OPENED FLOW WRAP PACKAGE, WITH THE TIP CAP NOT ASSEMBLED TO THE SYRINGE BARREL. NO ADDITIONAL DETAILS COULD BE CONFIRMED FROM THE PHOTOGRAPH. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER 306593, LOT 4268970. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DETECTED DURING PRODUCTION OF THE LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL MANUFACTURING STEPS AND FINAL INSPECTIONS MET APPLICABLE SPECIFICATION REQUIREMENTS. BASED ON THE AVAILABLE INFORMATION, INCLUDING THE PHOTOGRAPH, THE CUSTOMER REPORTED CONDITION IS CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.