BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD 60 DROP BI-FURCATED ADMIN SET

    MDR report key: 2902066 · Received November 28, 2012

    Report

    Report Number
    9616066-2012-00870
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    November 2, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A SET WAS LEAKING AT THE BIFURCATION. THERE WAS NO REPORT OF PT HARM OR REQUIRED MEDICAL INTERVENTION. THERE WERE NO SPECIFIC PT OR EVENT DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXGUARD 60 DROP BI-FURCATED ADMIN SET FPA CAREFUSION CORPORATION MA3139 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK