BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE

    MDR report key: 18535474 · Received January 17, 2024

    Report

    Report Number
    MW5150470
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 30, 2023
    Report Date
    January 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN GIVING COVID BOOSTER (SPIKEVAX NDC: 8077102-01) PHARMACIST WENT TO DEPRESS THE PLUNGER TO ADMINISTER THE VACCINE AND THE PLUNGER WOULD NOT MOVE. PHARMACIST DID NOTE SOME RESISTANCE TO EXPELLING THE AIR PRIOR TO ADMINISTRATION BUT NOT TO THE POINT SHE FOUND IT ALARMING. PHARMACIST ATTEMPTED TO GIVE THE VACCINE A SECOND TIME ONLY TO FIND THE SAME ISSUE. AFTER FIDDLING WITH THE VACCINE PHARMACIST RULED THE VACCINE (LOT 3030701 EXP 4/2024) TO BE COMPROMISED AND PATIENT ELECTED TO GET THE VACCINE ANOTHER DAY. AFTER FURTHER SCRUTINY IT LOOKS LIKE THE FAILURE WAS IN THE BD ECLIPSE NEEDLE, LOT 1217268, EXP 7/31/2026 AS IN COMPARISON TO ANOTHER NEEDLE APPEARED TO HAVE A SLIGHT BAND NEAR THE END OF THE NEEDLE, POSSIBLE INDICATING A MANUFACTURING ERROR OR BLOCKAGE. REF REPORT: MW5150471.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477480 BD ECLIPSE NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3030701

    Patients

    Seq Age Sex Outcome Treatment
    1 Male