BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INJECTOR LUER LOCK N35

    MDR report key: 12576376 · Received October 5, 2021

    Report

    Report Number
    3003152976-2021-00658
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 11, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE PHOTOS WERE VISUALLY INSPECTED, NO DAMAGE TO THE INJECTOR CANNULA, SAFETY SLEEVE, INJECTOR PISTONS OR INJECTOR LUER WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR LOT 2102002, AND NO DEVIATIONS OR NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS PROBLEM. THREE RETAINED SAMPLES FROM THE SAME LOT WERE USED FOR FURTHER EVALUATION. THE ENTIRE PRODUCT WAS VISUALLY INSPECTED AND NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE INJECTORS. ALL SAMPLES WERE PROPERLY CONNECTED TO A SYRINGE, SHIELD AND VIAL. AGAIN, THE LIQUID WAS ASPIRATED CORRECTLY AND WAS ABLE TO MOVE BETWEEN THE VIAL AND SYRINGE WITHOUT PROBLEMS, NO LEAKS OR LUER BREAKS OCCURRED. WE REVIEWED THE TESTING OF LOT 2102002 AND DID NOT IDENTIFY ANY ISSUES RELATED TO THE REPORTED INCIDENT. BASED ON OUR INVESTIGATION AND EVALUATION OF THE SAMPLE, WE ARE UNABLE TO IDENTIFY A CAUSE OF ROT RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD INJECTOR LUER LOCK N35 HAD A LUER CONNECTION BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PHASEAL INJECTOR SYSTEM BROKE AT THE SYRINGE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BD INJECTOR LUER LOCK N35 HAD A LUER CONNECTION BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "PHASEAL INJECTOR SYSTEM BROKE AT THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475763 BD INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515003 2102002 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1