BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 9417341 · Received December 5, 2019

    Report

    Report Number
    1024879-2019-02081
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 20, 2019
    Report Date
    February 25, 2020
    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
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING SAFETY SHIELD FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: -IT IS REPORTED CUSTOMER HAS BEEN EXPERIENCING DEFECTIVE "PINK NEEDLE SHIELDS" WHEN USING NEEDLE ECLIPSE. VERBIAGE RECEIVED IN EMAIL, - WE ARE CURRENTLY USING LOT 9200815, EXP 2024.07.31. LATELY WE HAVE BEEN EXPERIENCING A FAILURE OF THE PINK NEEDLE SHIELD. WHEN WE MOVE IT BACK, AND DRAW A PATIENT, THE NEEDLE SHIELD FALLS OFF. WE HAVE HAD THIS HAPPEN MULTIPLE TIMES TO MULTIPLE PHLEBOTOMISTS SINCE BEGINNING THIS LOT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING SAFETY SHIELD FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER HAS BEEN EXPERIENCING DEFECTIVE "PINK NEEDLE SHIELDS" WHEN USING NEEDLE ECLIPSE. VERBIAGE RECEIVED IN EMAIL, WE ARE CURRENTLY USING LOT 9200815, EXP 2024.07.31. LATELY WE HAVE BEEN EXPERIENCING A FAILURE OF THE PINK NEEDLE SHIELD. WHEN WE MOVE IT BACK, AND DRAW A PATIENT, THE NEEDLE SHIELD FALLS OFF. WE HAVE HAD THIS HAPPEN MULTIPLE TIMES TO MULTIPLE PHLEBOTOMISTS SINCE BEGINNING THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215577 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 9200815 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other