BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 11931092 · Received June 3, 2021

    Report

    Report Number
    3002682307-2021-00230
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A SMALL BLACK DOT ON THE BARREL OF THE SYRINGE WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2101037, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. 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. MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE AND INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE ANY EXCESS MATERIALS, REJECTING THE FIRST FEW PIECES. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS POSSIBLE THIS DOT IS EITHER BURNT MATERIAL FROM THE MOLDING PROCESS THAT IS EMBEDDED WITHIN THE SYRINGE OR INK FROM THE MARKING PROCESS, WITHOUT THE PHYSICAL SAMPLE WE CANNOT FULLY VERIFY THE COMPOSITION OR ORIGIN OF THE PARTICLE. A PROJECT HAS BEEN INITIATED TO REDUCE ANY FOREIGN MATERIAL WITHIN OUR PRODUCTS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 140 SYRINGES 20ML LL 120/PKG CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿TODAY IT WAS REPORTED FROM PRODUCTION THAT THERE IS A BLACK DOT IN THE 20ML BD SYRINGE MATERIAL ON EACH OF TWO SYRINGES (MATERIAL INCLUSION). AS A RESULT, THE ENTIRE STOCK WAS CHECKED 100% AND A TOTAL OF 140 SYRINGES WERE SEPARATED.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE NUMBER: (B)(6); INITIAL REPORTER FAX NUMBER: (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 140 SYRINGES 20ML LL 120/PKG CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿TODAY IT WAS REPORTED FROM PRODUCTION THAT THERE IS A BLACK DOT IN THE 20ML BD SYRINGE MATERIAL ON EACH OF TWO SYRINGES (MATERIAL INCLUSION). AS A RESULT, THE ENTIRE STOCK WAS CHECKED 100% AND A TOTAL OF 140 SYRINGES WERE SEPARATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828565 SYRINGE 20ML LL 120/PKG PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101037

    Patients

    Seq Age Sex Outcome Treatment
    1