BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 21335029 · Received February 7, 2025

    Report

    Report Number
    1213809-2025-00078
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 15, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 - SCALE MARKING ISSUE ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS THREE FULLY ASSEMBLED LOOSE 1 ML LL SYRINGES WITH VARYING CYLINDER DOT CONFIGURATIONS: TWO DOTS, ONE DOT, AND NO DOTS. THE BLACK DOTS NEXT TO THE BD LOGO OR GRAD LINES MONITOR THE ETCHINGS ON THE PRINT CYLINDER AND ARE PART OF THE PRINTED SCALE MARKING IMAGE. THESE DOTS ARE THERE BY DESIGN AND ARE NOT DEFECTS. A PRINTED IMAGE MAY HAVE ONE, TWO, OR NO DOTS PRINTED ALONG WITH THE SCALE MARKINGS. SINCE THE REPORTED DEFECT IS CUSTOMER AWARENESS AND NOT A TRUE DEFECT, NO CORRECTIVE ACTIONS ARE NECESSARY. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS EITHER ONE DOT, TWO DOTS OR NONE AND THEY OCCUR IN THE SAME PLACE. THIS PROBLEM AFFECTS MULTIPLE ITEMS AND IT IS ON ALL THE BATCHES WE HAVE IN STOCK. SO FAR IT HAS BEEN REPORTED TO US ON ITEMS 3001489 (301073), 3001490 (301027) AND 3009101 (309648). THE DOTS ARE APPEARING ON THE OUTSIDE AND WE BELIEVE IT MAY BE SOME MARKING? HOWEVER, THIS IS NOT A SERIOUS DEFECT AND THE ARTICLES MAY CONTINUE TO BE USED. WE HAVE ALSO FOUND SYRINGES ON WHICH THE SCALE IS LESS VISIBLE OR NOT VISIBLE AT ALL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100224 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown