BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE

    MDR report key: 17917003 · Received October 11, 2023

    Report

    Report Number
    3003152976-2023-00458
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 26, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    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

    PR 8971913 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 THE REPORTED LOT 2308754, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. 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, INCLUDING LEAKAGE TESTING. TEN RETAINED SAMPLES OF LOT 2308754 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED ON ANY OF THE SYRINGE COMPONENTS THAT COULD LEAD TO A LEAK AND ALL STOPPERS WERE VERIFIED TO BE PROPERLY ASSEMBLED ON TO THE PLUNGER ROD. LEAKAGE TESTING WAS PERFORMED AND PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT THE STOPPER ON THE 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE WAS LOOSE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: THE RUBBER OF THE PLUNGER OF A 20ML SYRINGE IS NOT AIRTIGHT. THE LEAK OCCURRED WHILE THE SYRINGE WAS BEING USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER ON THE 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE WAS LOOSE. THE FOLLOWING WAS TRANSLATED FROM FRENCH TO ENGLISH: THE RUBBER OF THE PLUNGER OF A 20ML SYRINGE IS NOT AIRTIGHT. THE LEAK OCCURRED WHILE THE SYRINGE WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311195 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2308754 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown