BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20219979 · Received September 14, 2024

    Report

    Report Number
    1213809-2024-00626
    Event Type
    Malfunction
    Date Received
    September 14, 2024
    Date of Event
    August 26, 2024
    Report Date
    January 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - LABEL / PRODUCT INSERT MISSING. THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE PHOTO SHOWS A BD INVOICE, SECOND PHOTO SHOWS THE BAG OF SYRINGES REMOVED FROM THE BOX CARTON, AND THIRD PHOTO SHOWS A PORTION OF ONE SIDE OF THE BOX CARTON. THE REPORTED DEFECT CANNOT BE CONFIRMED FROM THE PHOTOS PROVIDED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4173632. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS LABEL / PRODUCT INSERT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LABEL MISSING ON THE BOX. WHEN DID THE INCIDENT OCCUR? = BEFORE USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209407 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4173632 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown