SYRINGE 5ML SALINE FILL CHINA SP

Description of Event or Problem

PRIOR TO PRODUCT USE, THE PRINTED PRODUCTION DATE ON THE OUTER PACKAGING WAS 2024/7. HOWEVER, UPON OPENING THE PACKAGING, THE EXPIRATION DATE OF THE PRODUCT INSIDE WAS FOUND TO BE 2024/6, INDICATING THE PRODUCT HAD ALREADY EXPIRED. THIS CONSTITUTES AN ERROR IN THE PRINTED EXPIRATION DATE.

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 PACKAGING DISPLAYED A PRINTED PRODUCTION DATE OF 2024.07, HOWEVER, AFTER OPENING THE PACKAGE, THE PRODUCT INSIDE WAS FOUND TO HAVE AN EXPIRATION DATE OF 2024.06. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS A PACKAGING SHELF BOX SHOWING A MANUFACTURING DATE OF 2024 07 03 AND AN EXPIRATION DATE OF 2024 06 30. NO ADDITIONAL DETAILS COULD BE CONFIRMED FROM THE PHOTOGRAPH. THIS CONDITION COULD OCCUR IF A CONTINGENCY COMPUTER WAS USED NEAR THE END OF BATCH PRODUCTION, RESULTING IN A DISCREPANCY BETWEEN THE PRINTED DATES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306594, LOT 4177024. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS MET APPLICABLE SPECIFICATION REQUIREMENTS. THE ASSOCIATES HAVE BEEN INFORMED OF THIS ESCAPE. BASED ON THE INVESTIGATION AND THE AVAILABLE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.