BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 5ML SYRINGE

    MDR report key: 6926567 · Received October 7, 2017

    Report

    Report Number
    3002682307-2017-00062
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, WE CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS EMBEDDED CONTAMINATION IN THE TIP OF THE SYRINGE. 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 Nº2020 (FEBRUARY 13 - 15TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236 AND Nº4220, IN LOT #7041326 AND LOT #7034456. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7041288, #7034436, AND #7031187, RESEARCH HAS FOUND 1 QN (#(B)(4)) RELATED TO EMBEDDED CONTAMINATION IN THE BARREL. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7041293, #7034440, AND #7031191 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: THE EMBEDDED PARTICLES DEFECT WAS PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES (ABOUT 300ºC), SOME PARTICLES OF PLASTIC AND REST OF OIL FROM THE POLYETHYLENE CAN REMAIN STUCK ON THE INTERNAL WALLS OF THE MOLD AND GET BURNT. DURING NORMAL PRODUCTION SOME PARTICLE MAY BE DETACHED FROM THE SCREW BEING INJECTED AND REMAINING EMBEDDED IN MOLDED PIECE. THIS ISSUE WAS FOUND DURING PRODUCTION OF BARREL LOT #7041288, THE SEGREGATION OF THE PRODUCT WAS NOT CORRECTLY DONE BY THE OPERATOR AND THE PRESENCE OF ONE SYRINGE WITH EMBEDDED PARTICLES WAS PERMITTED. BY OTHER HAND, THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE TIP WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. CONFIRMATION: THE RETURNED AFFECTED SAMPLE PRESENTED EMBEDDED CONTAMINATION IN THE TIP OF THE SYRINGE. WE CONFIRMED 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD¿ 5ML SYRINGE, BEFORE USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706817 BD¿ 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1702183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other