BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 5ML SYRINGE

    MDR report key: 7001229 · Received November 3, 2017

    Report

    Report Number
    3002682307-2017-00083
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 20, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. THE EVALUATION OF THE PICTURE SHOWED THAT THERE WAS A BLACK PARTICLE IN THE SYRINGE BARREL. WE HAVE ALSO BEEN PROVIDED WITH THE AFFECTED SAMPLE, WHICH DID NOT PRESENT ANY BLACK PARTICLE. FINALLY WE IDENTIFIED THE BLACK PARTICLE OF THE PICTURE AS A PRINTING FOIL PARTICLE, CONFIRMING THE REPORTED ISSUE. THE RETURNED PICTURE OF THE SAMPLE PRESENTED A BLACK PARTICLE IN THE SYRINGE BARREL. WE COULD CONFIRM THE REPORTED ISSUE. 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 Nº2020 (APRIL 23 - 25TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, AND Nº4220, IN LOT #7100070 (APRIL 18 - 24TH, 2017) AND IN LOT #7112278 (APRIL 24TH - MAY 1ST, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. ROOT CAUSE DESCRIPTION: 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. THIS KIND OF PROCESS IS AN APPROVED AND HIGH CAPABLE PRINTING TECHNOLOGY FOR MEDICAL DEVICES, BUT IS SOME CIRCUMSTANCES THERE IS A POSSIBILITY THAT DURING THE SCALE STAMPING SOME MINOR INK SPECK COULD COME OFF REMAINING ATTACHED TO THE EXTERNAL SURFACE OF THE BARREL. THE PRESENCE OF THESE INK SPECKS SHOULD BE VERY LIMITED AND ALWAYS IN A VERY SHORT SIZE, NORMALLY INAPPRECIABLE UNDER NORMAL VISUAL CONDITIONS. IT IS CONCLUDED THAT THE RISK ASSOCIATED TO THIS ISSUE SHOULD BE VERY LOW TO NEGLIGIBLE AND SHOULD NOT REPRESENT ANY IMPACT TO THE HEALTH OF THE PATIENT OR USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLACK FOREIGN MATTER WAS ON THE SYRINGE BARREL OF A BD¿ 5ML SYRINGE BEFORE USE. THIS HAS OCCURRED NINE TIMES IN THE HOSPITAL. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779764 BD¿ 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1704177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other