BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 12367709 · Received August 25, 2021

    Report

    Report Number
    3002682307-2021-00436
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 21, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    50382903057608
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2011007. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, OUR ENGINEERS WERE NOT ABLE TO OBSERVE ANY FOREIGN MATTER. UNFORTUNATELY WITHOUT THE ABILITY TO OBSERVE THE REPORTED FAILURE MODE OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE OPEN SYRINGE PACKING TO DISCOVER DIRTY NEEDLE, WITHOUT CLEAR PLASTIC SAFETY CAP. SAME SHIPPED WITHOUT. NOT THE PINK SAFETY DEVICE BUT THE SAFETY CAP THAT COVERS THE NEEDLE. NEEDLE ITSELF WAS DIRTY, WITH LINT AND FIBERS. SAME DISCARDED.

    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 THE BD ECLIPSE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE OPEN SYRINGE PACKING TO DISCOVER DIRTY NEEDLE, WITHOUT CLEAR PLASTIC SAFETY CAP. SAME SHIPPED WITHOUT. NOT THE PINK SAFETY DEVICE BUT THE SAFETY CAP THAT COVERS THE NEEDLE. NEEDLE ITSELF WAS DIRTY, WITH LINT AND FIBERS. SAME DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264486 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 305760 2011007 50382903057608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown