BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 20416762 · Received October 10, 2024

    Report

    Report Number
    3003152976-2024-00543
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 30, 2024
    Report Date
    January 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K182589
    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)(6). FOLLOW UP MDR FOR DEVICE EVALUATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FUNCTIONAL TESTING WAS PERFORMED AND A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. FURTHER EVALUATION IDENTIFIED THE SYRINGE WAS DAMAGED NEAR THE 30ML MARKING, CAUSING THE LEAK WHEN THE STOPPER IS MOVED ACROSS THIS PORTION OF THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT: 2407124, NO DEVIATIONS OR NON-CONFORMANCE'S WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. SIX RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED ON ANY OF THE DEVICES AND NO LEAKAGES OCCURRED ON THE RETAINED PRODUCTS TESTED. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, BASED ON THE DAMAGE OBSERVED IT WAS DETERMINED THIS LIKELY OCCURRED DURING THE ASSEMBLY PROCESS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    SYRINGE UU STER 3PIECES 50ML: REF: 300865, LOT: 2407124, DLU: 30/06/2029, NUMBER OF UNITS CONCERNED: 1. DESCRIPTION OF EVENTS: PLUNGER LEAKAGE FROM SYRINGE. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: DM AVAILABLE FOR EXPERT APPRAISAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344472 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2407124 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown