BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (JELCO)PROTECTIV PLUS

    MDR report key: 304449 · Received November 9, 2000

    Report

    Report Number
    MW1020380
    Event Type
    Malfunction
    Date Received
    November 9, 2000
    Date of Event
    October 23, 2000
    Report Date
    November 3, 2000
    Manufacturer
    J+J MEDICAL INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHILD'S IV WAS WET. CATHETER APPEARED TO BE INTACT. FLUID OBSERVED TO BE SQUIRTING FROM HUB/CATHETER JUNCTION. A SMALL IMPERFECTION WAS NOTED IN THE CATHETER HUB. IV DISCONTINUED AND A NEW ONE WAS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (JELCO)PROTECTIV PLUS IV CATHETER FOZ J+J MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other