BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 17511839 · Received August 11, 2023

    Report

    Report Number
    3003916417-2023-00217
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 27, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THREE NEEDLES ARE OBSERVED INSIDE THE PACKAGING, NO DEFECTS OR ISSUES OBSERVED. UNABLE TO VERIFY THE MIXED NEEDLE INCIDENT BASED ON IMAGES. PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE'S PACKAGE HAD A 32MM AND 1 MM NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE NEEDLE IN QUESTION COMES WITH 2 SIZES, THE FIRST OF WHICH IS 2MM AS DESCRIBED ON THE PACKAGE, BUT THE PHYSICAL SHOWS 32MM AND 1MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE'S PACKAGE HAD A 32MM AND 1 MM NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE NEEDLE IN QUESTION COMES WITH 2 SIZES, THE FIRST OF WHICH IS 2MM AS DESCRIBED ON THE PACKAGE, BUT THE PHYSICAL SHOWS 32MM AND 1MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763351 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 2090319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown