BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO 23 G X 1 IN

    MDR report key: 11663903 · Received April 13, 2021

    Report

    Report Number
    MW5100753
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 9, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT INTO INFUSION FOR SQ DARZALEX FASPRO. INJECTION INITIATED ON LLQ WITHOUT INCIDENT UP UNTIL ROUGHLY 5ML REMAINED IN SYRINGE, WHEN RN NOTICED LEAKING BETWEEN BLUE NEEDLE HUB AND THE NEEDLE ADAPTER. AFTER TRYING TO ADJUST, NEEDLE HUB DETACHED FROM THE ADAPTER. NEEDLE WAS ABLE TO BE RE-SECURED AND THE REMAINDER OF MEDICATION WAS ADMINISTERED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555350 HYPODERMIC NEEDLE-PRO 23 G X 1 IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 4290

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR