BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL EURO 200 S/C

    MDR report key: 21964940 · Received May 5, 2025

    Report

    Report Number
    1213809-2025-00323
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 12, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - BARREL CRACKED. AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM FRENCH TO ENGLISH: REFERENCE NO: (B)(4). LOT: 230304. ON INJECTING A VIDAZA SYRINGE IN S/C, THE PRODUCT WAS FOUND TO BE BEADING AT THE BARREL OF THE CHEMOTHERAPY SYRINGE. AFTER INSPECTING THE SYRINGE, IT WAS FOUND TO BE CRACKED AT THE BARREL. THE DEVICE INVOLVED IN THE INCIDENT HAS ALREADY BEEN RETURNED TO YOU BY THE DEPARTMENT. 24-APR-2025: ADDITIONAL INFORMATION RECEIVED. THE INCIDENT TOOK PLACE ON (B)(6) 2025. A NEW SYRINGE WAS ADMINISTERED TO SUPPLEMENT THE FAULTY ONE. AS FAR AS THE DAMAGE IS CONCERNED, WE NOTE AN UNCERTAINTY IN THE DOSE ADMINISTERED AND AN ADDITIONAL WAITING PERIOD WHILE A NEW DOSE IS PREPARED. 25-APR-2025: ADDITIONAL INFORMATION RECEIVED. THANK YOU FOR YOUR FEEDBACK. UNFORTUNATELY, THE DEVICE WAS NOT KEPT. THE BATCH NUMBER IS 230904.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896329 BD SYRINGE 3ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown