BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY 2 NEEDLE

    MDR report key: 10200419 · Received June 25, 2020

    Report

    Report Number
    MW5095237
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SAFETY DEVICE ON HUBER NEEDLE DID NOT STAY ENGAGED ON NEEDLE TIP, WHICH CAUSED A NEEDLE STICK TO ME WHEN PLACING THE DEVICE IN THE SHARPS CONTAINER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657645 SURECAN SAFETY 2 NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INDUSTRIES SDN. BHD. 17N31G8670

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other