BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER.

    MDR report key: 7066604 · Received November 29, 2017

    Report

    Report Number
    1024879-2017-00656
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    February 4, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5182956. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY SHIELD CAME OFF WHEN TRYING TO CLOSE/ENGAGE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846023 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER. SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5182956 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other