BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS SAFETY NEEDLE

    MDR report key: 13584224 · Received February 22, 2022

    Report

    Report Number
    MW5107617
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 18, 2022
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SAFETY NEEDLE 23G X 1 1/2 INCH CREATED BY DPS HAD LEAKAGE OF PRODUCT WHEN ATTACHED TO SYRINGE. THE NEEDLE WAS TIGHTLY SCREWED ON THE SYRINGE. THE LEAKAGE HAPPENED BETWEEN THE BOTTOM OF THE NEEDLE. IT SEEMS THAT THE NEEDLE WAS NOT FULLY INTACT INTO THE HUB.

    Description of Event or Problem · 0

    SAFETY NEEDLE 23G X 1 1/2 INCH CREATED BY DPS HAD LEAKAGE OF PRODUCT WHEN ATTACHED TO SYRINGE. THE NEEDLE WAS TIGHTLY SCREWED ON THE SYRINGE. THE LEAKAGE HAPPENED BETWEEN THE BOTTOM OF THE NEEDLE. IT SEEMS THAT THE NEEDLE WAS NOT FULLY INTACT INTO THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672905 DPS SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI DUOPROSS MEDITECH CORPORATION 2011021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown