BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3 ML LL EURO 200 S/C

    MDR report key: 16109210 · Received January 5, 2023

    Report

    Report Number
    1213809-2022-01342
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    November 23, 2022
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE LIQUID PRESENT PAST THE STOPPER AND ACCUMULATED AROUND THE PLUNGER ROD. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT COULD NOT ESTABLISHED AT THIS TIME. THE PHYSICAL SAMPLE IS REQUIRED FOR MORE IN DEPTH INVESTIGATION OF ALL POTENTIAL CONTRIBUTING FACTORS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2221955. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 3 ML LL EURO 200 S/C LEAKAGE AND UNDERDOSAGE OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDICATION LIQUID GOT BEHIND THE PISTON. PATIENT WOULD HAVE RECEIVED TOO LITTLE MEDICATION DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313637 BD SYRINGE 3 ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 2221955 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown