BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 8940180 · Received August 28, 2019

    Report

    Report Number
    3002682307-2019-00467
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    30382903057604
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH SAMPLES FOR CATALOG 305760 LOT 1901010 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION UNDER A MICROSCOPE DID NOT REVEAL ANY CLOGGED CANNULA. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. DURING THE CANNULA ASSEMBLING PROCESS (FOR MICROLANCE AND ECLIPSE) THE NEEDLES ARE 100% INSPECTED USING A CAMERA SYSTEM. THIS CAMERA SYSTEM SENSES A LIGHT SOURCE WHICH IS POSITIONED AT THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION CONDITION MAY BE PRESENT AND AS A RESULT, THE NEEDLE IS AUTOMATICALLY REJECTED. THIS CAMERA IS CHALLENGED EVERY 8 WORKING HOURS. IN ADDITION OF THIS PREVENTIVE METHODOLOGY, THE NEEDLES ARE INSPECTED FOR THE OCCLUDED CANNULA CONDITION AS PART OF THE IN-PROCESS INSPECTION AFTER THE ASSEMBLING PROCESS EVERY 30 MINUTES. FRAGA PLANT IS PROVIDED WITH CLOSED CARTRIDGES OF CANNULAS BY SISTER BD PLANTS AND THE SAME CANNULA REFERENCES ARE USED FOR MICROLANCE 3 AND ECLIPSE. AS THIS IS THE FIRST TIME THIS LOT HAS BEEN REPORTED, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE OCCLUSION OCCURRED DURING USE WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONVERSION FROM CONVENTIONAL BD MICROLANCE 25G NEEDLE TO BD ECLIPSE 25G. SAME MEDICATION, SAME NEEDLE GAUGE, SAME SYRINGE, SAME NURSE BUT OCCLUSION OCCURRED IN THE NEEDLE WHILE INJECTING CHEMOTHERAPY SUBCUTANEOUS. THIS HAPPENED MULTIPLE TIMES ON DIFFERENT ONCOLOGY WARDS WITH DIFFERENT NURSES. " 10 OCCURRENCES WERE REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE OCCLUSION OCCURRED DURING USE WITH A BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONVERSION FROM CONVENTIONAL BD MICROLANCE 25G NEEDLE TO BD ECLIPSE 25G. SAME MEDICATION, SAME NEEDLE GAUGE, SAME SYRINGE, SAME NURSE BUT OCCLUSION OCCURRED IN THE NEEDLE WHILE INJECTING CHEMOTHERAPY SUBCUTANEOUS. THIS HAPPENED MULTIPLE TIMES ON DIFFERENT ONCOLOGY WARDS WITH DIFFERENT NURSES." 10 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732777 BD ECLIPSE NEEDLE BD ECLIPSE¿ NEEDLE FMI BECTON DICKINSON, S.A. 1901010 30382903057604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other