BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH NEEDLE

    MDR report key: 7412337 · Received April 10, 2018

    Report

    Report Number
    3002682307-2018-00082
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 24, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED PICTURE, 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 QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2011 (OCTOBER 3 - 5TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7269127 (OCTOBER 2 - 24TH, 2017) AND LOT #7244146 (SEPTEMBER 4 - 17TH, 2017). RESEARCH HAS FOUND 1 QN (#10008) RELATED TO EMBEDDED CONTAMINATION IN THE BARREL. WE HAVE ALSO REVIEWED THE BARREL LOTS #7244052, #7269061, AND #7271031, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7251469, #7244053, #7237230, #7211171, #7234129, #7282420, #7269060, AND #7258045 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 #7269127. THE SIZE OF THE REPORTED PARTICLE COULD NOT BE IDENTIFIED BY THE OPERATOR DURING THE SEGREGATION PROCESS. 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 PICTURE OF THE AFFECTED SAMPLE PRESENTED EMBEDDED CONTAMINATION IN THE TIP OF THE SYRINGE. WE CONFIRMED THE REPORTED ISSUE. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿A BLACK POINT¿) WAS FOUND ON THE TIP OF A BD¿ 20 ML SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253903 BD¿ 20 ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1710207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other