BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8025278 · Received October 31, 2018

    Report

    Report Number
    3002682307-2018-00260
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 17, 2018
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) INVESTIGATION SUMMARY: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE.WE HAVE ALSO REVIEWED THE BARREL LOTS #8149704, #8142762, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND.WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8149708, #8142766, #8135536. RESEARCH HAS FOUND 1 QN (#(B)(4)) FOR LOT #8149708, RELATED TO EMBEDDED CONTAMINATION IN THE PLUNGER IN MACHINE Nº3556. BD HAS BEEN PROVIDED WITH AN AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, BD CONFIRMS THE REPORTED ISSUE, AND IDENTIFIED THE BLACK TRACES AS EMBEDDED CONTAMINATION IN THE PLUNGER OF THE SYRINGE. AFTER ANALYZING THE AFFECTED SAMPLE PROVIDED TO THE MANUFACTURING SITE FOR EVALUATION, BD COULD SEE THE REPORTED FOREIGN MATTER AND CONFIRM THE REPORTED ISSUE. 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 PLUNGER LOT #8149708, THE SEGREGATION OF THE PRODUCT WAS NOT CORRECTLY DONE BY THE OPERATOR AND THE PRESENCE OF ONE SYRINGE WITH EMBEDDED PARTICLES WAS NOT AVOIDED. THIS A COSMETIC DEFECT WHICH HAS NO RISK TO THE HEALTH BECAUSE THE PLASTIC PIECE IS EMBEDDED IN THE PLUNGER OF THE SYRINGE WITHOUT POSSIBILITY OF BEING DETACHED FROM IT. INVESTIGATION CONCLUSION: BD HAS BEEN PROVIDED WITH AN AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, BD CONFIRMS THE REPORTED ISSUE, AND IDENTIFIED THE BLACK TRACES AS EMBEDDED CONTAMINATION IN THE PLUNGER OF THE SYRINGE. ROOT CAUSE DESCRIPTION: EMBEDDED PARTICLES IN THE PLUNGER OF THE SYRINGE COMING FROM THE INJECTION PROCESS OF THE PIECE. FAILURE IN THE SEGREGATION OF THE PRODUCT AFTER THE DETECTION OF THIS ISSUE DURING PRODUCTION (QN #(B)(4)). RATIONALE: BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT. BY OTHER HAND, THIS INCIDENT WILL BE COMMUNICATED IN THE PRODUCTION FLOOR TO PREVENT FUTURE FAILURES IN THE INSPECTION PROCESS OF NON-CONFORMING PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862976 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1806118

    Patients

    Seq Age Sex Outcome Treatment
    1 Other