BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CONVENIENCE TRAY EUROPE

    MDR report key: 18569640 · Received January 24, 2024

    Report

    Report Number
    3003152976-2024-00041
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 9, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903022380
    PMA / PMN Number
    NA
    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): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2310017, 2212081 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED. UPON VISUAL INSPECTION IT CAN BE OBSERVED THE PLASTIC TRAY IS DAMAGED. OVERPRESSURE LEAK TESTS HAVE BEEN PERFORMED TO DETERMINE IF THERE ARE ANY PERFORATIONS IN THE TRAY. THE RESULTS OBTAINED WERE SATISFACTORY. IT IS THEREFORE CONFIRMED THAT STERILITY IS MAINTAINED. THIS INCIDENT CAN BE PRODUCED DURING THERMO-FORMING OF THE FILM FOR THE TRAY OF THE PRODUCT. IF THE FILM IS EXPOSED TO HIGH TEMPERATURE MORE TIME THAN REQUIRED, FILM CAN BE DAMAGED CAUSING THE VISUAL DEFECTS NOTICED IN THE SAMPLES PROVIDED BY CUSTOMER. STERILITY IS NOT COMPROMISED IF THERE IS NO HOLE IN THE TRAY. STERILIZATION PROCESS INVESTIGATION WILL BE INITIATED TO VERIFY IF IT MAY AFFECT THE ASPECT OF THE TRAY. 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.

    Description of Event or Problem · 0

    THE SAME THAN (B)(4) : PACKAGING IS MELTED, THE PRESENCE OF BUBBLES AND PIMPLES CALLS INTO QUESTION THE MAINTENANCE OF THE INTEGRITY OF THE STERILIZATION OF THE PRODUCT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953910 SYRINGE 50ML LL CONVENIENCE TRAY EUROPE SYRINGE, PISTON FMF BECTON DICKINSON 2212081 00382903022380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown