BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ ECCENTRIC LUER-SLIP TWO-PIECE SYRINGE

    MDR report key: 6808396 · Received August 21, 2017

    Report

    Report Number
    3002682307-2017-00023
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    August 2, 2017
    Report Date
    September 12, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SAMPLE EVALUATION: NO SAMPLE AVAILABLE FOR EVALUATION. DHR 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 Nº2024 (MARCH 7 - 9TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, AND Nº4213, IN LOT #7055092 (FEBRUARY 27TH - MARCH 6TH, 2017) AND IN LOT #7062492 (MARCH 6 - 13TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7062448, #7055054, #7048394, #7048394, AND #7041288 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7062449, #7055058, #7048398, AND #7041293 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION: NO SAMPLES AVAILABLE FOR EVALUATION. NO ISSUE FOUND IN THE BHR. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD DISCARDIT¿ ECCENTRIC LUER-SLIP TWO-PIECE SYRINGE WAS LEAKING FLUID. THERE WAS NO REPORT OF MEDICAL INTERVENTIONS, EXPOSURE OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586647 BD DISCARDIT¿ ECCENTRIC LUER-SLIP TWO-PIECE SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1703131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other