BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE S/T 25X5/8 RB

    MDR report key: 12081007 · Received June 28, 2021

    Report

    Report Number
    3002682307-2021-00287
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 22, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903057603
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011007. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, BLACK PARTICLES WERE FOUND EMBEDDED WITHIN THE HUB COMPONENT. PER THE FEEDBACK AND IMAGES PROVIDED, THIS DEFECT WAS MOST LIKELY PRODUCED WITHIN THE INJECTION MOLDING MACHINES. DUE TO THE HIGH WORKING TEMPERATURES, IF THE GASES ARE NOT PROPERLY EXPELLED, BURNT PARTICLES CAN RESULT. THESE ARE COSMETIC DEFECTS WITH NO RISK TO HEALTH AS THE BURNT PARTICLES ARE EMBEDDED INTO THE PRODUCT WITHOUT THE POSSIBILITY OF DETACHMENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE ECLIPSE S/T 25X5/8 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BLACK RESIDUE ON ORANGE NEEDLE HUB.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE ECLIPSE S/T 25X5/8 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BLACK RESIDUE ON ORANGE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976780 NEEDLE ECLIPSE S/T 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2011007 00382903057603

    Patients

    Seq Age Sex Outcome Treatment
    1