BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE

    MDR report key: 7169148 · Received January 5, 2018

    Report

    Report Number
    3002682307-2017-00147
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 26, 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 · 1

    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.

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN PROVIDED WITH THE AFFECTED, WHICH PRESENTED FOREIGN MATTER PARTICLES INSIDE THE SYRINGE, WHAT CONFIRMED THE REPORTED ISSUE. 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 Nº2011 (B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7100073 (B)(6) 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7100035, AND #7089485 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7114316, #7100040, AND #7089486 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE RETURNED SAMPLE PRESENTED FOREIGN MATTER INSIDE THE SYRINGE. WE COULD CONFIRM THE REPORTED ISSUE. THE AFFECTED SAMPLE WAS RETURNED FOR OUR EVALUATION. AFTER THE EVALUATION OF THE SAMPLE AND THE DISCUSSION WITH OUR PRODUCTION SUPERVISORS, WE HAVE DETERMINED THAT THE FOREIGN MATTER OF THE NON-CONFORMANCE CONSISTS OF AN AMOUNT OF AGGLOMERATE DUST PARTICLES. THE DUST IN THIS CASE CAME FROM THE HOPPER OF THE ASSEMBLY MACHINE. IN THAT CASE, WE CONSIDER THAT BECAUSE OF A PUNCTUAL FAILURE IN THE CLEANING PROCEDURES BY THE OPERATOR, THE PRESENCE OF THIS PARTICULATES IN THE HOPPER WAS PERMITTED DURING MANUFACTURING. ON THE OTHER HAND, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF OCCURRENCE SHOULD BE VERY EXCEPTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD¿ 20 ML SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10874 BD¿ 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1704161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other