BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2ML BD DISCARDIT¿ II SYRINGE

    MDR report key: 7000563 · Received November 3, 2017

    Report

    Report Number
    3002682307-2017-00078
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 11, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. INVESTIGATION: INVESTIGATION SUMMARY. 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 PLUNGER. 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 Nº2026 (JULY 22 - 25TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4201 AND Nº4206, IN LOT #7198305 AND LOT #7202260. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7198287, #7187014, #7202241, AND #7205025 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 A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE PLUNGER WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. CONFIRMATION. THE RETURNED AFFECTED SAMPLE PRESENTED EMBEDDED CONTAMINATION IN THE PLUNGER. WE CONFIRMED THE REPORTED ISSUE. CAPA DETERMINATION. NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION. 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 PLUNGER. 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 Nº2026 (JULY 22 - 25TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4201 AND Nº4206, IN LOT #7198305 AND LOT #7202260. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7198287, #7187014, #7202241, AND #7205025 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION. 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 A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE PLUNGER WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. CONFIRMATION. THE RETURNED AFFECTED SAMPLE PRESENTED EMBEDDED CONTAMINATION IN THE PLUNGER. WE CONFIRMED THE REPORTED ISSUE. CAPA DETERMINATION. NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MOLD WAS FOUND ON A 2 ML BD DISCARDIT¿ II SYRINGE DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778883 2ML BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1707193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other