BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJETAK ADJUSTABLE TIP NEEDLE

    MDR report key: 7344658 · Received March 15, 2018

    Report

    Report Number
    MW5075901
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    March 14, 2018
    Report Date
    March 14, 2018
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING A LABORIE INJETAK ADJUSTABLE TIP NEEDLE, THE NEEDLE WAS NOT COMING OUT OF THE CATHETER FAR ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183464 INJETAK ADJUSTABLE TIP NEEDLE NEEDLE TIP CATHETER FBK LABORIE MEDICAL TECHNOLOGIES DIS199 D168088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR