BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD EXTENSION SET

    MDR report key: 2190072 · Received June 29, 2011

    Report

    Report Number
    9616066-2011-00346
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SET HAS BEEN RECEIVED HOWEVER THE INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN DONE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE CONNECTION BETWEEN THE STOPCOCKS SEPARATED ON THE EXTENSION SET. NO ADD'L PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXGUARD EXTENSION SET FPA CAREFUSION CORP MX4450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK