BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2082592 · Received April 27, 2011

    Report

    Report Number
    3005748548-2011-00012
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. ALTHOUGH REQUESTED, THE SET HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED ONCE THE SET HAS BEEN REC'D AN A FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN YOU TWIST THE FLUSH SYRINGE TO FLUSH, THE IV FLUID WON'T FLOW THROUGH THE CAP. NO HARM TO PT OR CLINICIAN REPORTED. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C MV051336

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BD 10ML NSS FLUSH SYRINGE: LOT UNK