BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20ML DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 6838350 · Received September 1, 2017

    Report

    Report Number
    3002682307-2017-00034
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 10, 2017
    Report Date
    October 11, 2017
    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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BHR REVIEW: 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 Nº2022 (AUGUST 4 - 5TH, 2015). SYRINGES WERE ASSEMBLED IN LOT #5233404 AND IN LOT #5240044. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. ROOT CAUSE ANALYISIS: THE ACCURATE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. DESPITE THE FACT THAT ANY HIGH VOLUME MANUFACTURING PROCESS MAY GENERATE SOME PARTICULATE MATTER, THE HIGHLY CAPABLE PROCESS EMPLOYED BY BD TO PRODUCE DISCARDIT SYRINGES KEEPS PARTICULATE MATTER TO EXTREMELY LOW LEVELS THROUGH STRINGENT MANUFACTURING PROCESSES AND ENVIRONMENTAL CONTROLS. IN BD (B)(4), THE WHOLE PROCESS TO ASSEMBLY AND PACKAGE THE PRODUCT TAKES PLACE IN AN ENVIRONMENTAL CONTROLLED ROOM WHERE THE AIR IS CONTINUOUSLY FILTERED USING A HEPA FILTER SYSTEM AND THERE ARE SEVERAL STRICT MEASURES. CONFIRMATION: NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION. WE COULD NOT 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.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A 20ML DISCARDIT¿ II SYRINGE W/O NEEDLE, BEFORE USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618679 20ML DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1508163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other