BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML

    MDR report key: 8896541 · Received August 15, 2019

    Report

    Report Number
    3002682307-2019-00451
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 21, 2019
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 309050 LOT 1903206 TO INVESTIGATE FOR THIS RECORD. THE FOREIGN MATTER WAS IDENTIFIED AS PRINTING FOIL PARTICLES IN THE FLUID PATH. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PROCESS USED TO PRINT THE SCALE IN BD EMERALD SYRINGES IS CALLED "HOT STAMPING" PROCESS, IN WHICH, THROUGH A HEATED METAL STAMP, THE SCALE IS TRANSFERRED FROM THE PRINTING FOIL TO THE BARREL. IN SOME CASES, THIS PRINTING FOIL DUE TO A CLOG IN THE PRINTING STATION, HAS TO BE CUTE BY THE OPERATOR. WHEN THIS SITUATION HAPPENS, THE MACHINE STOPS AUTOMATICALLY, AND THE OPERATOR SHOULD CUT THE PRINTING FOIL REEL TO SOLVE THE CLOG. DURING THIS CUTTING PROCESS OF THE PRINTING FOIL, SOME PARTICLES COULD REMAIN IN THE MACHINE, AND IN THIS CASE, THESE FOIL PARTICLES FINALLY ENDED IN ONE SYRINGE BARREL, PRODUCING THE REPORTED ISSUE. THEREFORE, THE REPORTED NONCONFORMANCE IS CAUSED BY A DEFECTIVE FOIL REEL AND HUMAN ERROR. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE S2 5ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: FM FOUND IN THE ORIGINAL PACKAGE. THE DEVICE HAS BEEN DESTROYED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED WITH A BD SYRINGE S2 5ML. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: FM FOUND IN THE ORIGINAL PACKAGE. THE DEVICE HAS BEEN DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691128 BD SYRINGE S2 5ML SYRINGE FMF BECTON DICKINSON, S.A. 1903206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other