BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 23253894 · Received October 9, 2025

    Report

    Report Number
    1213809-2025-00637
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO OF THE 10ML BOX CASE LABEL (PART NUMBER 302995) FROM BATCH 5141360 WAS REVIEWED, CONFIRMING THAT THE LABEL DISPLAYED THE CORRECT EXPIRATION DATE OF 2030-04-30. HOWEVER, THE CERTIFICATE OF COMPLIANCE (COC) FOR THE SAME BATCH LISTED AN INCORRECT EXPIRATION DATE OF 2030-05-29. UPON INVESTIGATION, BOTH STERILE AND NON-STERILE BATCH RECORDS WERE EVALUATED AND FOUND TO BE FREE OF ANY ISSUES RELATED TO THE REPORTED CONDITION. THE DISCREPANCY WAS DETERMINED TO BE THE RESULT OF A CLERICAL ERROR IN THE CERTIFICATE OF COMPLIANCE (COC), WHICH HAS SINCE BEEN CORRECTED, AND THE UPDATED CERTIFICATE OF COMPLIANCE (COC) HAS BEEN ATTACHED. ADDITIONALLY, A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 5141360. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THIS INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 LABEL CONTENT WAS INCORRECT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:MATERIAL #302995; LOT #5141360.  VERBATIM:RCC RECEIVED A COMPLAINT VIA EMAIL.FROM REC TEAM:THIS IS SOMETHING THAT'S NEVER HAPPENED TO ME BEFORE. THE EXPIRATION DATE ON THE COC IS DIFFERENT FROM THE PRODUCT ITSELF. ANOTHER COLLEAGUE AND I LOOKED AT ALL THE MATERIALS, AND THEY HAD AN EXPIRATION DATE OF 2030-04-30. WE LOOKED AT THE PRODUCT ITSELF, AND IT ALSO HAD THE SAME EXPIRATION DATE. IN THIS CASE, WHAT SHOULD WE DO? I WON'T RECEIVE IT UNTIL WE HEAR SOMETHING.ITEM -302995,LOT - 5141360.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566139 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5141360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown