BD SYRINGE 5ML SALINE FILL CHINA SP
Received Jan 16, 2026 · Event occurred Dec 29, 2025
Report 1911916-2026-00011 · MDR key 24092722
Device
Generic name
Saline, Vascular Access Flush
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
306594
Lot number
4177024
Product problems
- Inaccurate Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INCORRECT EXPIRATION DATE WAS DISCOVERED ON THE INNER PACKAGING. TO SUPPORT THE INVESTIGATION, A SINGLE PHOTOGRAPH WAS PROVIDED AND EVALUATED BY THE QUALITY TEAM. THE IMAGE SHOWS A SHELF BOX LABEL BEARING A MANUFACTURING DATE OF 2024 07 03 AND AN EXPIRATION DATE OF 2024 06 30. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY HAVE OCCURRED IF THE SHELF BOX LABEL PRINTER WAS SERVICED OR ADJUSTED DURING BATCH SETUP. 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 PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. ASSOCIATES WILL BE NOTIFIED OF THIS ESCAPE. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE PHOTO SAMPLE, THE CUSTOMER REPORTED SYMPTOM IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THE SYRINGE 5ML SALINE FILL CHINA SP LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO PRODUCT USE, AN INCORRECT EXPIRATION DATE WAS DISCOVERED PRINTED ON THE INNER PACKAGING. AFFECTED QUANTITY: (B)(4) UNITS (47 BOXES). SAMPLES CANNOT BE RETURNED; PHOTOGRAPHIC EVIDENCE IS AVAILABLE. GREEN CLAIMS PROCESSING IS NOT REQUIRED; RETURN/EXCHANGE IS NECESSARY. A COMPLAINT RESPONSE LETTER IS REQUIRED; A COMPLAINT RECEIPT CONFIRMATION IS REQUIRED. UPON FURTHER VERIFICATION, A TOTAL OF 57 CARTONS ((B)(4) UNITS) OF INTERMEDIATE PACKAGING HAVE BEEN AFFECTED BY THE PRINTING ERROR. THIS REPORT IS HEREBY SUBMITTED FOR YOUR INFORMATION. THANK YOU.