BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 19111174 · Received April 15, 2024

    Report

    Report Number
    3003152976-2024-00229
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 25, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903022380
    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), FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2310017, 2311125, AND 2212081, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES OF THE REPORTED LOTS WERE USED FOR ADDITIONAL EVALUATION. THE TRAYS WERE INSPECTED AND WERE FOUND TO BE VISUALLY DAMAGED. PRESSURIZED TESTING WAS PERFORMED, THERE WAS NO HOLES OR OTHER DAMAGE WITHIN THE TRAYS, CONFIRMING THE STERILITY IS MAINTAINED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON OUR INVESTIGATION, THE DAMAGE OBSERVED WAS DETERMINED TO BE A VISUAL DEFECT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, A PROJECT HAS BEEN INITIATED TO FURTHER REVIEW THE STERILIZATION PROCESS TO VERIFY IF IT MAY AFFECT THE VISUAL APPEARANCE OF THE TRAY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION AND REGRET ANY INCONVENIENCES IT MAY HAVE CAUSED. 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. 2 ADDITIONAL BATCHES REPORTED: BATCH: 2310017. BATCH CREATION DATE: 2023-09-26. BATCH EXPIRATION DATE: 2028-09-30. BATCH: 2311125. BATCH CREATION DATE: 2023-11-20. BATCH EXPIRATION DATE: 2028-10-31.

    Description of Event or Problem · 0

    SOME PACKAGING IS AS IF IT HAD MELTED.

    Description of Event or Problem · 0

    SOME PACKAGING IS AS IF IT HAD MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975144 SYRINGE 50ML LL CONVENIENCE TRAY EUROPE SYRINGE, PISTON FMF BECTON DICKINSON 2212081 00382903022380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown