BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    72" LINE W/ 0.2 FILTER

    MDR report key: 1003755 · Received February 22, 2008

    Report

    Report Number
    9616567-2008-00013
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    FPA
    PMA / PMN Number
    K860803
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION INTO THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SET FAILED WHERE THE TUBE GOES INTO THE FILTER. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 72" LINE W/ 0.2 FILTER FLUID ADMINISTRATION SET FPA SMITHS MEDICAL, ASD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK