BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2963000 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00034
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE EXTENSION SET HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV EXTENSION SET BROKE IN HALF WHEN CLAMPED. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33272 MAXPLUS EXTENSION SET FPA CAREFUSION CORPORATION MPX5302-C 12095879

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK