BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO MAPCATH STYLET

    MDR report key: 2890503 · Received December 5, 2012

    Report

    Report Number
    2890503
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    July 20, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CORPAK MEDSYSTEM
    Product Code
    FOK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    0.8 FR CORPAK SENSOR STYLET (LOT #4488)WAS PLACED IN 2FR BARD PER-Q-CATH PICC LINE (LOT# REWC0364 EXP.2014-03) PICC PLACE IN PATIENT AND WAS HAVING MALPOSITION TO JUGULAR VEIN. ATTEMPTED PROPER POSITION STYLET WAS REMOVED AND NOTED TO HAVE BROKEN OFF IN THE PATIENT. RETRIEVED 4 DAYS LATER. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO MAPCATH STYLET PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER AC FOK CORPAK MEDSYSTEM 30-2-8 4488
    2 2FR BARD PER-Q-CATH PICC LINE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 FOZ BARD ACCESS SYSTEMS, INC. * REWC0364

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO OTHER