BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS ADMINISTRATION SET

    MDR report key: 1333729 · Received January 22, 2009

    Report

    Report Number
    9616066-2009-00040
    Event Type
    Malfunction
    Date Received
    January 22, 2009
    Report Date
    January 11, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    CARDINAL HEALTH SALES REPRESENTATION WAS INFORMED BY CUSTOMER THAT THE SET WAS LEAKING RIGHT ABOVE THE FILTER. HAVE PLACED A CALL TO CUSTOMER TO OBTAIN THE SET FOR INVESTIGATION AND TO OBTAIN CLINICAL INFORMATION. PRODUCT NOT RECEIVED AS OF THE TIME OF THIS REPORT. IF PRODUCT RECEIVED, A FOLLOW UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS ADMINISTRATION SET FPA CARDINAL HEALTH ALARIS PRODUCTS 10015415 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK