BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 376496 · Received February 12, 2002

    Report

    Report Number
    376496
    Event Type
    Malfunction
    Date Received
    February 12, 2002
    Date of Event
    January 28, 2002
    Report Date
    February 11, 2002
    Manufacturer
    BECTON DICKENSON, BD MEDICAL SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC INTRAVENOUS LINE WAS INSERTED WITH PROPER PLACEMENT CONFIRMED BY X-RAY. THE CATHETER APPEARED TO MIGRATE. IT WAS MANIPULATED AND SUBSEQUENTLY DISCONTINUED, NOTING THAT THE CATHETER TIP WAS BROKEN OFF. THE CATHETER TIP FRAGMENT WAS CONFIRMED BY X-RAY TO BE IN THE PT'S RIGHT VENTRICLE. THE CATHETER TIP WAS REMOVED UNDER FLUOROSCOPY IN THE CARDIAC CATHETERIZATION LAB WITHOUT SEQUALAE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PICC LINE DQO BECTON DICKENSON, BD MEDICAL SYSTEMS L CATH 1.9 FRENCH 102805

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DAY