BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 19058614 · Received April 8, 2024

    Report

    Report Number
    3003152976-2024-00210
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903031726
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP MDR FOR DEVICE EVALUATION: TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE PRODUCTS, A PLASTIC LIKE FILAMENT WAS OBSERVED WITHIN ONE OF THE DEVICES, NO FOREIGN MATTER OR OTHER CONTAMINATION WAS IDENTIFIED WITHIN THE OTHER DEVICE RETURNED. CHARACTERIZATION TESTING WAS PERFORMED AND FOUND THE PIECE OBSERVED WAS CONSISTENT WITH POLYPROPYLENE. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR LOT 2201701, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. TEN RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS VISUALLY INSPECTED, NO BURRS OR FLASHES ON THE THREADING WAS OBSERVED AND NO ISSUES WITH THE PACKAGING WAS FOUND. 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. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE FOUND. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THE PLASTIC FILAMENT GENERATED DURING THE MOLDING PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    A HAIR INSIDE A 1 ML SYRINGE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419462 SYRINGE 1ML LS SP120 SYRINGE, PISTON FMF BECTON DICKINSON 2201701 00382903031726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown