BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH VAXCEL

    MDR report key: 370884 · Received January 8, 2002

    Report

    Report Number
    MW1023783
    Event Type
    Malfunction
    Date Received
    January 8, 2002
    Date of Event
    January 7, 2002
    Report Date
    January 8, 2002
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE CARE OF PICC CATHETER - NOTED LEAKING JUST MEDIAL OF WINGS WHEN FLUSHED WITH NS. FOUND SMALL HOLE IN RED LUMEN SIDE OF CATHETER. CATHETER REMOVED INTACT. REPLACED WITH MEDLINE CATHETER TO CONTINUE THERAPY AS ORDERED. CATHETER PLACED AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH VAXCEL PICC DQO BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other