BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK SYRINGE WITH 21 G X 1 1/2 IN

    MDR report key: 6880453 · Received September 20, 2017

    Report

    Report Number
    3002682307-2017-00052
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 30, 2017
    Report Date
    October 9, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. THE EVALUATION SHOWED THAT NO SCALE WAS PRINTED IN THE SYRINGE BARREL. THAT CONFIRMED THE REPORTED ISSUE. DHR 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 (JANUARY 24 - 26TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4260, AND Nº4267, IN LOT #7023226 (JANUARY 23 - 29TH, 2017) AND IN LOT #7023228 (JANUARY 23 - 30TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7024033, #7016124, AND #7023227 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS THE PROCESS WE USE TO PRINT THE SCALE IS CALLED "HOT STAMPING SYSTEM". A METAL STAMP IS HEATED AT AROUND 100ºC. BETWEEN THE STAMP AND THE BARREL, WE INTERPOSE A SPECIAL BLACK PRINTING FOIL. BY PRESSURE, THE STAMP PUSHES THE PRINTING FOIL AND ITS COMPONENT IS EMBEDDED IN THE BARREL WALL. THE RESULT IS A BLACK SCALE PRINTED ON THE BARREL OF THE SYRINGE. THE REPORTED ISSUE SHOULD HAPPENED AT THE END OF THIS PROCESS, DUE TO A DEFECTIVE FOIL REEL. IN THIS CASE THE FOIL DID NOT WORK AS EXPECTED, AND THE SCALE WAS NOT PRINTED CORRECTLY. WHEN THIS SITUATION HAPPENS, THE MACHINE STOPS AUTOMATICALLY AND THE OPERATOR SHOULD REMOVE THE DEFECTIVE SYRINGES FROM THE PROCESS. THEREFORE, THE REPORTED NONCONFORMANCE IS CAUSED BY A DEFECTIVE FOIL REEL AND HUMAN ERROR. CONFIRMATION: THE RETURNED PICTURE OF THE SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD 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.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE 10 ML BD LUER-LOK SYRINGE WITH 21 G X 1 1/2 IN CAME WITH NO SCALE MARKINGS. FOUND BEFORE USE. NO SERIOUS OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658102 10 ML BD LUER-LOK SYRINGE WITH 21 G X 1 1/2 IN SYRINGE FMF BECTON DICKINSON, S.A. 1701224

    Patients

    Seq Age Sex Outcome Treatment
    1 Other