BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS T-CONNECTOR EXTENSION SET

    MDR report key: 3173181 · Received June 5, 2013

    Report

    Report Number
    9616066-2013-00434
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS DISCARDED. THE CUSTOMER COMPLAINT OF SET PULLED APART BY PATIENT COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS ABLE TO PULL THE T EXTENSION SET APART AT THE JUNCTION OF THE TUBING AND T ACCESS PORT. THERE WAS NO REPORT OF PATIENT HARM OR OF MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL PATIENT OR EVENT DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249404 MAXPLUS T-CONNECTOR EXTENSION SET FPA CAREFUSION CORPORATION MPXT1003-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK