BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL SYRINGE

    MDR report key: 18809639 · Received February 29, 2024

    Report

    Report Number
    1213809-2024-00133
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 9, 2024
    Report Date
    August 26, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    FOUR PHOTOS WERE RECEIVED AND EVALUATED BY BD. THE FIRST TWO PHOTOS SHOW DIFFERENT ANGLES OF A LOOSE 10 ML LL SYRINGE WITH A NEEDLE AND WHAT APPEARS TO BE LIQUID. IT¿S ALSO REVEALED THAT THE SCALE MARKING IS MISSING ENTIRELY. THE LAST TWO PHOTOS SHOW A LOOSE 3 ML LL SYRINGE WITH A RED CAP ATTACHED TO IT WITH MORE THAN 50% OF THE GRADING LINES OF A SECTION OF THE SCALE MARKING MISSING, SPECIFICALLY BETWEEN THE ZERO LINE AND NUMBER 1 ½. NO 5 ML LL EURO SYRINGE SAMPLE OR PHOTO WAS PROVIDED. SINCE NO SAMPLES FOR THE REPORTED PRODUCT DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE UNNECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3240901 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 · 0

    IT WAS REPORTED THAT BD CONVENTIONAL SYRINGE SCALE MARKINGS ARE FADING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: AS EXPLAINED BY PHONE, A COMPLAINT HAS COME IN TO PHARMACY OF STERILE LUER-LOCK SYRINGES OF 5 AND 10ML. THE PROBLEM IS THAT THE GRADATIONS/PRINTING ON THE SYRINGES IS FADING, MAKING IT IMPOSSIBLE TO READ HOW MANY MILLILITERS HAVE BEEN PULLED UP IN THE SYRINGE, PHOTOS SEE ATTACHED. THE FADING OCCURS AFTER ONE PULL-UP OF A LIQUID (I.E. THE SYRINGE IS NOT REUSED + IS NOT IN DIRECT CONTACT WITH E.G. DISINFECTANT), SO AFTER ONLY MINIMAL AND LIMITED MANIPULATION OF THE SYRINGE. THIS HAS BEEN NOTICED TWICE IN THE PREPARATION UNIT OF THE PHARMACY. I DO NOT HAVE A LOT NUMBER OF THE SPECIFIC CASES, BUT I CAN SEE WHICH LOTS ARE CURRENTLY BEING USED. MY QUESTION IS IF THIS COMPLAINT HAS ALREADY BEEN REPORTED AND/OR THIS PROBLEM IS ALREADY KNOWN. COULD THIS BE LINKED TO A SPECIFIC LOT OR HAS THERE BEEN A RECENT CHANGE TO THE PRINTING OF THE SYRINGES?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498184 BD CONVENTIONAL SYRINGE SYRINGE, PISTON FMF BECTON DICKINSON MEDICAL SYSTEMS 3240901 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown