BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 5ML SYRINGE

    MDR report key: 7188433 · Received January 12, 2018

    Report

    Report Number
    3002682307-2017-00161
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 20, 2017
    Report Date
    January 25, 2018
    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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. NO DEFECT WAS OBSERVED IN THIS PROVIDED SAMPLE. WE COULD NOT CONFIRM THE REPORTED ISSUE. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (FEBRUARY 6 - 8TH, 2015). SYRINGES WERE ASSEMBLED IN MACHINE (B)(4), IN LOT #5023297 (JANUARY 27 - 30TH, 2015), AND IN LOT #5030428 (FEBRUARY 5 - 9TH, 2015). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #5023276, #5029132, #5015087, AND #5009018, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. CONCLUSION: NO ABSOLUTE ROOT CAUSE. THE PROVIDED SAMPLE DID NOT PRESENT ANY DEFECT. WE COULD NOT CONFIRM THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE SCALE MARKINGS ON A BD EMERALD¿ 5ML SYRINGE. THE SCALE MARKINGS WERE REPORTED TO GRADUATE EVERY 0.2 ML INSTEAD OF THE INTENDED 0.5 ML. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31982 BD EMERALD¿ 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1502129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other