BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ WITH NEEDLE

    MDR report key: 7485711 · Received May 3, 2018

    Report

    Report Number
    3002682307-2018-00119
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 11, 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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. BHR REVIEW/ WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. THE REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2025 (JUNE 21ST - JULY 8TH, 2017). SYRINGES WERE ASSEMBLED IN LOT #7187046, #7156015 AND #7160155. NEEDLES WERE ASSEMBLED IN MACHINE, Nº4413, IN LOT #7163006 (JUNE 13 - 21ST, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. GIVEN THE AVAILABLE INFORMATION WE WERE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. ANY TYPE OF HIGH VOLUME MANUFACTURING MAY GENERATE SOME PARTICULATE MATTER, HOWEVER, BD PERFORMS THOROUGH INSPECTIONS IN ORDER TO REDUCE ANY TYPE OF FOREIGN MATTER IN OUR PRODUCTS. THE ENTIRE PROCESS, FROM ASSEMBLY TO PACKAGING OF THE PRODUCT, TAKES PLACE IN AN ENVIRONMENTALLY CONTROLLED ROOM. GIVEN OUR STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS, WE CONCLUDE THAT IT HAS BEEN AN ISOLATED ISSUE AND THE PROBABILITY OF RECURRENCE IS VERY LOW. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE 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 GREEN FOREIGN MATTER WAS FOUND IN AND/OR ON THE NEEDLE/BARREL OF A BD SYRINGE¿ WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325108 BD SYRINGE¿ WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1707104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other