BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 2082567 · Received April 27, 2011

    Report

    Report Number
    3005748548-2011-00011
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 11, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED ONCE THE SET HAS BEEN RECEIVED AND A FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TUBING BROKE OFF IN THE MAXPLUS CLEAR CONNECTOR. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HOSPIRA FILTER SET, PART # AND LOT NUMBER UNK