BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 8557996 · Received April 26, 2019

    Report

    Report Number
    3002682307-2019-00273
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 29, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 301940 LOT 1810132 TO INVESTIGATE FOR THIS RECORD. AFTER VISUAL EXAMINATION, THE FOREIGN MATTER HAS BEEN IDENTIFIED AS PRINTING FOIL PARTICLES OUTSIDE THE FLUID PATH. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE PROCESS USED TO PRINT THE SCALE IN BD DISCARDIT 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 MUST BE CUTE BY THE OPERATOR DUE TO A CLOG IN THE PRINTING STATION. 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. THEREFORE, THE REPORTED NONCONFORMANCE WAS CAUSED BY A DEFECTIVE FOIL REEL AND HUMAN ERROR. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ SYRINGE S2 5ML 22GA 1-1/4IN THERE WAS BLACK FOREIGN MATTER IN THE BARREL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT WAS FOUND THE BARREL WITH BLACK FOREIGN MATTER BEFORE USING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ SYRINGE S2 5ML 22GA 1-1/4IN THERE WAS BLACK FOREIGN MATTER IN THE BARREL. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND THE BARREL WITH BLACK FOREIGN MATTER BEFORE USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346836 BD SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1810132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other