BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD ¿ SYRINGE WITH DETACHED NEEDLE

    MDR report key: 7384044 · Received March 29, 2018

    Report

    Report Number
    3002682307-2018-00085
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AN INVESTIGATION HAS BEEN COMPLETED WITH THE AFFECTED SAMPLE RETURNED FOR EXAMINATION. THE ANALYSIS OF THE SAMPLE SHOWED SMALL BLACK PARTICLES IN THE EXTERNAL SURFACE OF THE TIP. AS A RESULT, THIS DISCOVERY VERIFIES THE REPORTED ISSUE. THE REPORTED FOREIGN MATTER CONSISTED OF GREASE. THE PRESENCE OF THIS GREASE CONTAMINATION WAS DUE TO AN INCORRECT PRACTICE OF THE CLEANING PROCEDURES, SO THIS ALLOWED THE PRESENCE OF THIS GREASE IN SOME AREA OF THE MACHINE. THAT PRODUCED THE POSSIBILITY OF CONTACT WITH THE TIP OF THE SYRINGE AND THE REPORTED NONCONFORMANCE. BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF RECURRENCE SHOULD BE VERY EXCEPTIONAL. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2029 (FEBRUARY 19 - 23RD, 2014). SYRINGES WERE ASSEMBLED IN MACHINES Nº4258, AND Nº4218 IN LOT #4045437 (FEBRUARY 18 - 25TH, 2014), AND IN LOT #4031066 (FEBRUARY 4 - 11TH, 2014). RESEARCH HAS FOUND 1 QN (#5087) RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #4045391, #4031420, #4016047, AND #4024196, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BEFORE USE OF THE BD EMERALD ¿ SYRINGE WITH DETACHED NEEDLE THERE WAS FOREIGN MATTER IN THE PATHWAY. THE NURSE STATED ¿BLACK FOREIGN MATTER WAS IN THE TOP OF SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226966 BD EMERALD ¿ SYRINGE WITH DETACHED NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1402610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other