BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SAFETY NEEDLE, 25G X 0.625"

    MDR report key: 12985029 · Received December 10, 2021

    Report

    Report Number
    MW5105966
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING INJECTION OF A MEDICATION THE NURSE BEGAN TO COMPRESS THE PLUNGER TO ADMINISTER THE MEDICATION AND NOTED THAT THE MEDICATION WAS LEAKING FROM AROUND THE BASE OF THE NEEDLE. THE NURSE ATTEMPTED TO TIGHTEN THE NEEDLE ONTO THE SYRINGE BUT UPON ATTEMPTING A SECOND TIME TO INJECT THE MEDICATION IT WAS NOTED THAT MEDICATION WAS STILL COMING OUT FROM AROUND THE BASE OF THE NEEDLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871876 MEDLINE SAFETY NEEDLE, 25G X 0.625" SYRINGE, ANTISTICK MEG MEDLINE INDUSTRIES, LP - NORTHFIELD 02911067

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male