BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y CONNECTOR WITH ROTATING MALE LUER LOCK

    MDR report key: 1000255 · Received February 14, 2008

    Report

    Report Number
    9616567-2008-00007
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    December 29, 2007
    Report Date
    January 15, 2008
    Manufacturer
    SMITHS MEDICAL, ASD.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT 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 WHILE THE SET WAS BEING PLACED THE TUBING PULLED APART. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y CONNECTOR WITH ROTATING MALE LUER LOCK CONNECTOR FPA SMITHS MEDICAL, ASD. NA 1171243

    Patients

    Seq Age Sex Outcome Treatment
    1 UN