BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH NEEDLE

    MDR report key: 7268144 · Received February 13, 2018

    Report

    Report Number
    3002682307-2018-00015
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 20, 2018
    Report Date
    February 19, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AN INVESTIGATION WAS COMPLETED AFTER EXAMINATION WITH THE AFFECTED SAMPLE THAT WAS RETURNED. THE SAMPLE SHOWS FOREIGN MATTER INSIDE THE BARREL WHICH IS IDENTIFIED AS DUST PARTICLES FROM THE ASSEMBLY PROCESS. THIS VERIFIES THE REPORTED ISSUES. 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 (APRIL 22 - 23RD, 2017). SYRINGES WERE ASSEMBLED IN MACHINES Nº4252, AND Nº4251 IN LOT # 7100073 (APRIL 18 - 29TH, 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 WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7089486, #7100040, AND #7114316, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. CONCLUSION: 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. THE CAUSE OF THIS IS A PUNCTUAL FAILURE IN THE CLEANING PROCEDURES BY THE OPERATOR, THE PRESENCE OF THIS PARTICULATES IN THE HOPPER WAS PERMITTED DURING MANUFACTURING. 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. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO OTHER ACTIONS ARE REQUIRED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BARREL OF A BD¿ 20 ML SYRINGE WITH NEEDLE WHEN DRAWING UP A SOLUTION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111806 BD¿ 20 ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1704162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other