BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS NEEDLELESS CONNECTOR

    MDR report key: 2935517 · Received January 4, 2013

    Report

    Report Number
    9616066-2012-00910
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 17, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECENT ISSUES WITH THE MAXPLUS VALVE STICKING, THEN POPPING AND SPRAYING. STATED THE BLUE GLAND IN THE VALVE STUCK IN THE OPEN POSITION, THEN AFTER A SLOW RETURN IT POPPED CLOSED AND SPRAYED BLOOD ON THE USER. THE CUSTOMER HAD USED MAXPLUS FOR MORE THAN 5 YRS WITHOUT ANY ISSUES. THE REPORT OF STICKING AND THEN SPRAYING STARTED A FEW MONTHS AGO. THE IV TEAM MEMBERS PLACE OR REPLACE THE MAXPLUS VALVE AND IT IS ONLY USED ON CENTRAL LINES. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL PT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5803 MAXPLUS NEEDLELESS CONNECTOR FPA CAREFUSION CORP MP1000-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CENTRAL LINE, MFR/MODEL/LOT# UNK