BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N AUTOGUARD

    MDR report key: 7977020 · Received October 18, 2018

    Report

    Report Number
    7977020
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 12, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERIPHERAL IV ACCESS WAS ATTEMPTED ON A NEONATE UNSUCCESSFULLY. THERE WAS NO DIFFICULTY WITH ABILITY TO PUNCTURE SKIN AND OBTAIN VEIN ACCESS BUT CATHETER WOULD NOT ADVANCE FURTHER INTO THE VEIN. CATHETER RESISTS/STICKS AND TRACKS THE SKIN, REFUSING TO THREAD. ATTEMPTED WITH MULTIPLE LOTS. LOT# 8059638, 8107753, 8100635, 6363889, 6197861, AND 8107753.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818444 BD INSYTE-N AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 381511 8107753

    Patients

    Seq Age Sex Outcome Treatment
    1