BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 20774769 · Received November 25, 2024

    Report

    Report Number
    3003152976-2024-00614
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 23, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    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 THE REPORTED LOT 2408024, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. 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. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO FOREIGN MATTER OR OTHER PARTICLES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE 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.

    Description of Event or Problem · 0

    A FOREIGN OBJECT FOUND IN AN UNOPENED STERILE 50ML SYRINGE LOT 2408024 EXP 31/07/2029. FORTUNATELY, THIS WAS NOTICED BEFORE SETTING UP THE INFUSION AND THE PROCESS WAS RESTARTED.

    Description of Event or Problem · 0

    A FOREIGN OBJECT FOUND IN A UNOPENED STERILE 50ML SYRINGE LOT 2408024 EXP 31/07/2029. FORTUNATELY THIS WAS NOTICED BEFORE SETTING UP THE INFUSION AND THE PROCESS WAS RESTARTED. I CAN CONFIRM THAT THE SYRINGE WAS DISPOSED OF BY A THIRD PARTY UNFORTUNATELY. I PERSONALLY VIEWED THE SYRINGE AND IT LOOKED LIKE A SMALL PIECE OF ORGANIC MATTER (LIKE A BROWN LEAF) APPROXIMATELY 4MM X 3MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014256 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2408024 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown