BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11516815 · Received March 18, 2021

    Report

    Report Number
    3003152976-2021-00149
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE STOPPER WAS VERIFIED TO BE INCORRECTLY ASSEMBLED, PARTIALLY DETACHED FROM THE PLUNGER ROD. THERE WAS NO VISIBLE DAMAGE OR DEFECTS IN THE PLUNGER THAT COULD HAVE CONTRIBUTED TO THIS DEFECT. 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. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2010062, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE ASSEMBLY MACHINE HAS A VISION SYSTEM TO DETECT FOR MISSING OR IMPROPERLY ASSEMBLED STOPPERS. THERE WERE NO INCIDENTS DOCUMENTED RELATED TO ANY FAILURES WITH THE DETECTION SYSTEM, THEREFORE WE CANNOT IDENTIFY WHY THE IMPACTED SAMPLE WAS NOT DISCARDED. BASED ON OUR INVESTIGATION, IT WAS DETERMINED THIS INCIDENT OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY, THE IMPACTED UNIT NOT BEING PROPERLY DISCARDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND A DEFECT IN A 50 ML SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE 50ML LL WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND A DEFECT IN A 50 ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414976 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010062

    Patients

    Seq Age Sex Outcome Treatment
    1