SYRINGE 5ML SALINE FILL CHINA SP

Additional Manufacturer Narrative

(B)(4). FOLLOW UP. THE CUSTOMER REPORTED THAT THE OUTER PACKAGING DISPLAYED A PRODUCTION DATE OF 2024 07 03, HOWEVER, UPON OPENING THE PACKAGE, THE PRODUCT INSIDE SHOWED AN EXPIRATION DATE OF 2024 06 30. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE PHOTOGRAPH DEPICTS A SHELF CARTON LABELED WITH A MANUFACTURING DATE OF 2024 07 03 AND AN EXPIRATION DATE OF 2024 06 30. NO ADDITIONAL DETAILS COULD BE CONFIRMED FROM THE IMAGE. THIS CONDITION COULD OCCUR IF A CONTINGENCY COMPUTER WAS USED NEAR THE END OF THE LOT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306594, LOT 4177024. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT WOULD EXPLAIN THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. ASSOCIATES HAVE BEEN INFORMED OF THIS ESCAPE. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC EVIDENCE PROVIDED, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

Description of Event or Problem

IT IS REPORTED, DATE PRINTED ON THE OUTER PACKAGING FOR (B)(6) 2024, BUT OPEN THE PACKAGE FOUND INSIDE THE PRODUCT'S EXPIRATION DATE OF 2024/6/30, HAS EXPIRED.

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.