BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP

    MDR report key: 6919400 · Received October 6, 2017

    Report

    Report Number
    3002682307-2017-00066
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 26, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THERE WERE TWO LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1605145, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2016-05-04. MEDICAL DEVICE LOT #: 1604109, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2016-03-29. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. INVESTIGATION: WE HAVE BEEN PROVIDED WITH THREE SAMPLES. THE EVALUATION OF THE SAMPLES DID NOT REVEAL ANY FUNCTIONAL LACK. THE SYRINGES DID NOT PRESENT ANY DEFECT. LOT 1604109: 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 Nº2013 ((B)(6), 2016). SYRINGES WERE ASSEMBLED IN MACHINES Nº4258, Nº4219, Nº4218, Nº4207, IN LOT #6082148 ((B)(6) 2016), AND IN LOT #6074136 ((B)(6) 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6082077, #6068218, #6070324, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6070321, #6082134, #6068219, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. LOT 1605145: 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 Nº2013 ((B)(6) 2016). SYRINGES WERE ASSEMBLED IN MACHINES Nº4219, Nº4207, IN LOT #6130155 ((B)(6) 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6130213, #6122325, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6130214, #6122328, AND NO PROBLEMS, DEFECTS OR QN WERE FOUND. ROOT CAUSE ANALYSIS THE INTENTION OF EMERALD WAS TO PROVIDE A TRULY GLOBAL PRODUCT, CE MARKED 510K AUTHORIZED (FDA) AND PREQUALIFIED FOR WHO (PQS). BASED ON THE NON CONFORMANCE DESCIPIRTION, IN THIS CASE THE COMPLAINT IS REGARDING AN UNFAMILIARITY WITH THE DEVICE FUNCTIONALITY. WE CAN STATE THAT NO MANUFACTURING DEFECT WAS AFFECTING THE PROVIDED SAMPLES. CONFIRMATION: THE RETURNED SAMPLES DID NOT PRESENT ANY FUNCTIONAL ISSUE. WE COULD NOT CONFIRM THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PLUNGER ON A BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP WAS DIFFICULT TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705485 BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other