BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLESS CONNECTOR

    MDR report key: 3063781 · Received April 3, 2013

    Report

    Report Number
    9616066-2013-00220
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF VALVES COMING OFF WHEN INJECTING CONTRAST COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE HOSPITAL RECENTLY SWITCHED FROM THE CLAVE TO THE MAXPLUS CLEAR VALVE. REPORT REC'D FROM RADIOLOGY THAT THE MAXPLUS VALVES ARE COMING OFF WHEN THEY ARE INJECTING CONTRAST FOR CTS. NO PT OR STAFF HARM REPORTED. CUSTOMER STATED THAT PRODUCT WOULD NOT BE RETURNED BECAUSE PRODUCT WAS DISCARDED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135489 MAXPLUS CLEAR NEEDLESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK