BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE CATHETER

    MDR report key: 11602563 · Received March 31, 2021

    Report

    Report Number
    MW5100479
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN STARTING IV-THE #18 INSYTE WAS NOT TAPED LIKE IT SHOULD HAVE BEEN-RESULTING IN BEING STUCK TWICE FOR IV-CATHETER SAVED. LOT NUMBER 0080382. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497539 INSYTE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0080382

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR