BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STRAIGHT SET 2Y MLL

    MDR report key: 978976 · Received November 21, 2007

    Report

    Report Number
    9616567-2007-00030
    Event Type
    Malfunction
    Date Received
    November 21, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 24, 2007
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K925219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER WAS UNCERTAIN OF THE EXACT LOT NUMBER, SO REPORTED THE FOLLOWING NINE LOTS WITH THE CORRESPONDING MFR DATES: 1180827-06/07, 1180830-07/07, 1180829-06/07, 1180825-06/07, 1180831-07/07, 1180834-07/07, 1180828-06/07, 1180826-06/07, 1180835-07/07. THE PRODUCT HAS BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION INTO THIS ISSUE. AN ADDITIONAL REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE TUBING IS PULLING OUT WHERE THE TUBING GOES INTO THE CASSETTE. THE REPORTER STATED THAT, IN SOME INSTANCES, THE CLINICIANS WERE PULLING ON THE TUBING PRIOR TO PLACEMENT ON THE PT. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL STRAIGHT SET 2Y MLL ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. NA VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN