BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9280462 · Received November 5, 2019

    Report

    Report Number
    1024879-2019-01914
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    July 30, 2019
    Report Date
    December 10, 2019
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 WITH THE NEEDLE SEPARATING FROM THE HOLDER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WHOLE NEEDLE SLID OUT OF THE CAP AND SHIELD ATTACHMENT, EXPOSING THE ENTIRE NEEDLE. LA WAS TRYING TO ATTACH NEEDLE TO HOLDER - WHEN ATTEMPTING TO SCREW THE NEEDLE ON THE HOLDER, THE WHOLE NEEDLE SLID OUT OF THE CAP AND SHIELD ATTACHMENT, EXPOSING THE ENTIRE NEEDLE. HAPPENED TWICE FOR LOT #9060948, EXP 2024-02-09.

    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 HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND WITH THE NEEDLE SEPARATING FROM THE HOLDER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WHOLE NEEDLE SLID OUT OF THE CAP AND SHIELD ATTACHMENT, EXPOSING THE ENTIRE NEEDLE. LA WAS TRYING TO ATTACH NEEDLE TO HOLDER. WHEN ATTEMPTING TO SCREW THE NEEDLE ON THE HOLDER, THE WHOLE NEEDLE SLID OUT OF THE CAP AND SHIELD ATTACHMENT, EXPOSING THE ENTIRE NEEDLE. HAPPENED TWICE FOR LOT #9060948, EXP 2024-02-09.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070965 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9060948 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other