BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 10ML SYRINGE

    MDR report key: 7007482 · Received November 7, 2017

    Report

    Report Number
    3002682307-2017-00091
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 13, 2017
    Report Date
    December 8, 2017
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. NO DEFECT WAS OBSERVED IN THESE PROVIDED SAMPLES. WE HAVE TESTED THE VOLUME ACCURACY OF THE SAMPLE AND STAND OUT THAT THE VOLUME DEOSSIFICATION WAS CORRECT. 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 Nº2015 (MARCH 18 - 19TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. SYRINGES WERE ASSEMBLED IN MACHINE (B)(4), IN LOT #7072007 (MARCH 13 - 23RD, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOT #7072006, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOT #7072494, #7062457, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE STOPPER LOT #7072497, #7062459, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: WE CAN CONFIRM THAT THE SCALE OF OUR SYRINGES BELONGS TO THE VOLUME INDICATED ON IT. CONFIRMATION: THE PROVIDED SAMPLE DID NOT PRESENT ANY DEFECT. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD EMERALD¿ 10ML SYRINGE WAS FOUND DURING USE MISSING THE + /-0.4ML. MARKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787715 BD EMERALD¿ 10ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1707379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other