BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLES

    MDR report key: 7321492 · Received March 7, 2018

    Report

    Report Number
    3002682307-2018-00045
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 14, 2018
    Report Date
    February 20, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: OUR MANUFACTURING FACILITY RECEIVED THE AFFECTED SAMPLE. UPON EVALUATION WE WERE ABLE TO IDENTIFY FOREIGN MATTER EMBEDDED IN THE PLUNGER. A BATCH HISTORY REVIEW WAS PERFORMED AND SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. WE CONCLUDED THE EMBEDDED PARTICLES WERE PRODUCED IN THE SCREW OF THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES, SOME PARTICLES OF PLASTIC AND OIL FROM THE POLYPROPYLENE CAN REMAIN STUCK ON THE INTERNAL WALLS OF THE MOLD AND GET BURNT. DURING NORMAL PRODUCTION SOME PARTICLES MAY BE DETACHED FROM THE SCREW BEING INJECTED AND REMAIN EMBEDDED IN MOLDED PIECE. THIS DEFECT DOES NOT POSE ANY RISK TO THE HEALTH OF THE PATIENT AS IT IS EMBEDDED IN THE PLUNGER WITHOUT THE POSSIBILITY OF BEING DETACHED. 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 QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (MAY 14 - 17TH, 2017). SYRINGES WERE ASSEMBLED IN LOT #7132495, #7128281, #7118091, AND #7112277. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7132417, #7125072, #7118049, #7114313, #7089479, AND #7100037 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 POLYPROPYLENE 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD MICROLANCE¿ NEEDLES WAS FOUND WITH FOREIGN MATTER ¿WHEN OPENING THE PACKAGING THE HCW SPOTTED MARK ON THE PLASTIC PART.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163422 BD MICROLANCE¿ NEEDLES NEEDLE FMI BECTON DICKINSON, S.A. 1705165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other