BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7058695 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00285
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 18, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: PHOTOGRAPHS WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. ACCORDING TO THE GENERAL NOTES FROM CRS, POSSIBLE LOT NUMBERS COULD INCLUDE 5200527 OR 5167571. CONCLUSION: THE PHOTOS CONFIRM THE REPORTED INCIDENT. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CAN BE DETERMINED AS BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER CONTAINED WHITE EPOXY LIKE, FOREIGN MATTER, ATTACHED ON THE SURFACE OF THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841054 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other