BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20GA 1.25IN CATHETER

    MDR report key: 12180123 · Received July 16, 2021

    Report

    Report Number
    12180123
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IV CATHETER SYSTEM HAD A HOLE IN THE TUBING. AFTER INSERTION OF IV, BLOOD OOZED OUT OF A HOLE IN THE TUBING THAT IS EXTENDED FROM THE NEEDLE. BD NEXIVA 20 GA 1.25 IN CATHETER WITH LOT NUMBER 1113420. IV WAS REMOVED AND REINSERTED UNNECESSARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079892 BD NEXIVA 20GA 1.25IN CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 1113420

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA