BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE WITH NEEDLE

    MDR report key: 7906839 · Received September 25, 2018

    Report

    Report Number
    3003916417-2018-00250
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DHR WAS REVIEWED TO THE SYRINGE BATCH 6012268 - SYRINGE 3ML LL 21X1-1/2 EMERALD SLA, CATALOG #302977, VERIFYING QUALITY NOTIFICATION AND MAINTENANCE ANALYSIS AND NO OCCURRENCES WERE OBSERVED. NO SAMPLE OR IMAGE WERE PROVIDED FOR EVALUATION. RETAINED SAMPLES TO THE BARREL COMPONENT (CODE: (B)(4), BATCH: 6013036) WERE VERIFIED AND SUBMITTED TO VALIDATED DIMENSIONAL TESTS AND NO DEVIATIONS WERE OBSERVED. THUS IT WAS NOT POSSIBLE CONFIRM THE OCCURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD EMERALD SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 WITH THE USE OF THE BD EMERALD¿ SYRINGE WITH NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746653 BD EMERALD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 6012268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other