BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 9767818 · Received February 28, 2020

    Report

    Report Number
    3002682307-2020-00070
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 1, 2020
    Report Date
    April 10, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, THE SCALE ON TWO OF THE SYRINGES WAS OBSERVED TO BE MISSING, THE THIRD SAMPLE HAD LIGHT LINES BUT THE SCALE WAS NOT LEGIBLE. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 1904243 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 PROCEDURE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED DUE A FAILURE IN THE TRANSFER OF INK FROM THE DRUM TO THE BARREL DURING THE MARKING PROCESS. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 50ML LL CLEAR 14GA 1-1/4IN EXPERIENCED LIGHT/MISSING SCALE MARKINGS. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS MISSING SCALE ON SOME OF THE SYRINGES OR THE SCALE IS ONLY WEAKLY PRINTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 50ML LL CLEAR 14GA 1-1/4IN EXPERIENCED LIGHT/MISSING SCALE MARKINGS. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS MISSING SCALE ON SOME OF THE SYRINGES OR THE SCALE IS ONLY WEAKLY PRINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235597 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1904243

    Patients

    Seq Age Sex Outcome Treatment
    1 Other