BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL

    MDR report key: 11056139 · Received December 22, 2020

    Report

    Report Number
    3003152976-2020-00576
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 16, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE PHOTO AND ONE HUNDRED AND EIGHTY SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, TWENTY FOUR BLISTERS WERE OBSERVED WITH NO DEFECT, THE REMAINING ONE HUNDRED AND FIFTY-SIX BLISTERS WERE MISSING EITHER PARTIAL OR COMPLETE NON-VARIABLE INFORMATION, ALL VARIABLE INFORMATION (LOT, EXPIRATION DATE, ETC.) WAS VISIBLY PRINTED ON THE BLISTER PAPER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003226, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THE REPORTED 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. WHILE NO DIRECT ISSUE WAS IDENTIFIED, IT WAS CONFIRMED THIS INSTANCE OCCURRED AS A RESULT OF HUMAN ERROR, THE PAPER ROLL NOT BEING PROPERLY REPLACED BY THE MACHINE OPERATOR. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 30ML LL WAS MISSING A LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCORRECT LABELING. THE STOCK WITHOUT THE CORRECT LABELLING HAS BEEN FOUND IN THEATRE AT MMH, ACTION TEAM HAVE CHECKED AND WILL QUARANTINE ANY STOCK UNTIL ADVISED WHAT TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519654 SYRINGE 30ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2003226

    Patients

    Seq Age Sex Outcome Treatment
    1