BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS MEDICAL

    MDR report key: 1632432 · Received March 11, 2010

    Report

    Report Number
    1632432
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    January 6, 2010
    Report Date
    March 11, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL STOPCOCK, 4-WAY WITH SWIVEL MALE LUER LOCK FMG SMITHS MEDICAL ASD, INC. * UNK
    2 B.BRAUN DISK FILTER, 1.2 UM FPB B.BRAUN MEDICAL INC. * UNK
    3 KENDALL UMBILICAL VESSEL CATHETER, 3.5FR X 15 IN. OS TYCO HEALTHCARE GROUP LP ARGYLE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 DAY Required Intervention